Long-term cost-effectiveness of transcatheter mitral valve repair in HF patients with secondary mitral regurgitation.

AIMS: The long-term cost-effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long-term cost-effectiveness of MitraClip added to guideline-directed medical therapy vs. guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. METHODS AND RESULTS: A two-stage (decision + Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re-hospitalization, and death and were calculated based on the 5 year follow-up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country-specific rates. The primary outcome was the lifetime incremental cost-effectiveness ratio. The mean age of the base case in our model was 72.2 years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re-hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality-adjusted life-year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost-effectiveness ratios of ¥468 462, £28 910, €26 045, and $71 199 per quality-adjusted life-year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost-effective in mainland China, the United Kingdom, Germany, and the United States at the country-specific willingness-to-pay thresholds. CONCLUSIONS: MitraClip + guideline-directed medical therapy was cost-effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system.

Comparison of cardiac biomarkers on risk assessment of contrast-associated acute kidney injury in patients undergoing cardiac catheterization: A multicenter retrospective study.

AIM: Cardiac biomarkers' predictive value of contrast-associated acute kidney injury (CA-AKI) remains unclear. We analysed whether creatine kinase isoenzyme-MB (CKMB), cardiac troponin I (cTnI) and preoperative N-terminal pro-brain natriuretic peptide (NT-proBNP) are tied to CA-AKI patients undergoing cardiac catheterization. METHODS: In the multi-center study, we included 3553 people underwent cardiac catheterization for analysis. CA-AKI was defined as the absolute increase of over 0.3 mg/dL or an increase of more than 50% compared with the baseline serum creatinine within 48 hours following cardiac catheterization. Logistic regression model and receiver operating characteristic (ROC) curves were used to examine the association between cardiac biomarkers and CA-AKI and the efficacy of Mehran risk score (MRS) model on CA-AKI prediction with and without cardiac biomarkers. RESULTS: Among 3553 people, 200 people eventually developed CA-AKI. The logistic regression model showed that log10 CKMB (odds ratio (OR): 1.97, 95%CI:1.51-2.57, p < .001), cTnI (OR: 1.03, 95%CI: 1.02-1.04, p < .001) and log10 NT-proBNP (OR: 3.19, 95%CI: 2.46-4.17, p < .001) were independent predictors of CA-AKI. The ROC curve demonstrated that area under the curve (AUC) of MRS was 0.733. CKMB, cTnI and NT-proBNP all significantly improved the AUC value in combination with MRS model. (NT-proBNP: 0.798, p < .001; CKMB: 0.758, p = .003; cTnI: 0.755, p = .002), among which the NT-proBNP had the best predictive efficacy improvement. CONCLUSION: Cardiac biomarkers of CKMB, cTnI and NT-proBNP are all independently associated with CA-AKI among patients undergoing cardiac catheterization while NT-proBNP remains the best indicator. Adding CKMB, cTnI and NT-proBNP to MRS improved the prognostic efficacy and may be considered effective tools to predict the risk of CA-AKI in clinical practice.

Establishment and assessment of a preclinical model of acute kidney injury induced by contrast media combined acute myocardial ischemia reperfusion surgery.

Acute kidney injury (AKI) is a common complication after acute myocardial infarction (AMI) in clinical practice, and the majority of previous preclinical models were induced by a single factor. The objective of the present study was to establish a stable preclinic model of AKI induced by contrast media (CM) with acute myocardial ischemia reperfusion surgery and to identify the effect of oxidative stress on kidney injury. Rats were treated individually or with CM or myocardial ischemia reperfusion surgery. Renal baseline and AKI parameters, the level of oxidative stress and histopathological images were examined along with AKI biomarkers. Results showed the incidence of AKI in the CM group and ischemia reperfusion injury (IRI) group was 40%, χ2 test (P<0.05 vs. CM-IRI) and 35%, χ2 test (P<0.05 vs. CM-IRI) and the combination group had the highest incidence rate 75%. IRI surgery combined with CM diminished kidney function and induced oxidative stress by increasing creatinine, blood urea nitrogen and reactive oxygen species levels. Western blotting showed that the early AKI biomarker of NGAL and KIM-1 increased and that the combination group had the highest value. Pathology damage exhibited severe kidney damage in the combination group compared with other control groups. The present research established a reliable preclinic model of post-AMI AKI with a stable and high postoperative AKI rate. Additionally, CM was demonstrated to exacerbate AKI caused by acute myocardial infarction through oxidative stress and, thus, oxidative stress may be a potential therapeutic target.

Volumetric assessment is superior to axial measurements in estimating the outcome of patients with acute uncomplicated type B aortic intramural haematoma.

OBJECTIVES: Our goal was to investigate the accuracy of the two-dimensional and three-dimensional computed tomography imaging features in predicting the progression of acute uncomplicated type B aortic intramural haematoma (IMH). METHODS: This study retrospectively screened 140 patients diagnosed with acute uncomplicated type B IMH in our institution from January 2015 to December 2020. Patients were classified as exhibiting progression (aortic dissection, aortic rupture, aneurysm formation, ulcer-like projection depth >10 mm or >10% increase in the initial thickness of the aortic wall) and regression (completely or partially reabsorbed haematoma) based on follow-up computed tomography. RESULTS: During the 11.4-month follow-up [interquartile range (IQR), 2.6-17.8], 55 patients had haematoma progression. The progression group had higher haematoma volume (HV) and total lesion volume [94.8 (IQR, 80.0-108.2) cm3 vs 40.3 (IQR, 30.8-57.9) cm3; 278.0 (IQR, 238.6-369.3) cm3 vs 197.3 (IQR, 152.8-235.9) cm3, both P < 0.001) and longer lesion length [43.2 (IQR, 37.5-46.7) cm vs 30.4 (IQR, 28.1-37.6) cm, P < 0.001)] than the regression group. According to the area under the curve, HV > 66 cm3 is the greatest risk factor for haematoma progression. In multivariable analysis, HV was a powerful independent predictive factor for type B IMH progression, with a hazard ratio of 17.9 (95% confidence interval, 5.5-58.7; P < 0.001). CONCLUSIONS: Volumetric parameters may help to predict disease progression more precisely for patients with acute uncomplicated type B IMH compared to standard axial measurements, which might optimize the initial treatment and follow-up protocol.

Economic Burden of Myocardial Infarction Combined With Dyslipidemia.

Background: Dyslipidemia is a common comorbidity and an important risk factor for myocardial infarction (MI). This study aimed to examine the economic burden of MI combined with dyslipidemia in China. Methods: Patients who were hospitalized due to MI combined with dyslipidemia in 2016 were enrolled. Costs were measured based on electronic medical records and questionnaires. The annual costs were analyzed by conducting descriptive statistics, univariable, and multivariable analyses. Results: Data of 900 patients were analyzed, and 144 patients were dead during the follow-up. The majority of patients were aged 51-70 years (n = 563, 62.55%) and males (n = 706, 78.44%). For all-cause costs, the median annual direct medical costs, direct non-medical costs, indirect costs, and total costs were RMB 13,168 (5,212-29,369), RMB 600 (0-1,750), RMB 676 (0-1,787), RMB 15,361 (6,440-33,943), respectively; while for cardiovascular-related costs, the corresponding costs were RMB 12,233 (3,795-23,746), RMB 515 (0-1,680), RMB 587 (0-1,655), and RMB 14,223 (4,914-28,975), respectively. Lifestyle and complications significantly affected both all-cause costs and cardiovascular-related costs. Conclusions: Increasing attention should be paid to encourage healthy lifestyle, and evidence-based medicine should focus on optimal precautions and treatments for complications, to reduce the economic burden among MI patients with a comorbid dyslipidemia.

Influence of Sex on Outcomes After Thoracic Endovascular Repair for Type B Aortic Dissection.

We aimed to investigate whether sex differences influence the clinical outcomes of patients who undergo thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD). We retrospectively analyzed a prospectively maintained single-center cohort of patients with TBAD who underwent TEVAR between January 2010 and June 2017. We evaluated the in-hospital and long-term mortality and composite end point. Of the 913 patients, 793 (86.8%) were male and 120 (13.1%) were female. Compared to male patients, the female patients were older, more likely to have diabetes mellitus, but less likely to smoke or have hypertension. The proximal landing zone in 0 and 1 was higher in male patients (P = .023), who were more likely to require an aortic arch bypass. Endoleak, delirium, and ICU stay after stent-graft implantation were also more frequent in men. Sex factor was not associated with in-hospital or long-term mortality or the composite end point in the multivariable regression analyses and Cox regression model. The mean estimated survival time was similar between males and females (2462.9 ± 141.2 vs 2804.1 ± 117.4 days, P = .167) in the propensity score-matched cohort. Despite distinct characteristics between sex, there was no sex-related difference in long-term clinical outcomes after TEVAR for TBAD.

Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction.

BACKGROUND: Diabetes mellitus (DM) is associated with increased cardiovascular (CV) risk. We compared health-related quality of life (HRQoL), healthcare resource utilization (HRU), and clinical outcomes of stable post-myocardial infarction (MI) patients with and without DM. HYPOTHESIS: In post-MI patients, DM is associated with worse HRQoL, increased HRU, and worse clinical outcomes. METHODS: The prospective, observational long-term risk, clinical management, and healthcare Resource utilization of stable coronary artery disease study obtained data from 8968 patients aged ≥50 years 1 to 3 years post-MI (369 centers; 25 countries). Patients with ≥1 of the following risk factors were included: age ≥65 years, history of a second MI >1 year before enrollment, multivessel coronary artery disease, creatinine clearance ≥15 and <60 mL/min, and DM treated with medication. Self-reported health status was assessed at baseline, 1 and 2 years and converted to EQ-5D scores. The main outcome measures were baseline HRQoL and HRU during follow-up. RESULTS: DM at enrollment was 33% (2959 patients, 869 insulin treated). Mean baseline EQ-5D score (0.86 vs 0.82; P < .0001) was higher; mean number of hospitalizations (0.38 vs 0.50, P < .0001) and mean length of stay (LoS; 9.3 vs 11.5; P = .001) were lower in patients without vs with DM. All-cause death and the composite of CV death, MI, and stroke were significantly higher in DM patients, with adjusted 2-year rate ratios of 1.43 (P < .01) and 1.55 (P < .001), respectively. CONCLUSIONS: Stable post-MI patients with DM (especially insulin treated) had poorer EQ-5D scores, higher hospitalization rates and LoS, and worse clinical outcomes vs those without DM. Strategies focusing specifically on this high-risk population should be developed to improve outcomes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01866904 (https://clinicaltrials.gov).

Patient-level and system-level barriers associated with treatment delays for ST elevation myocardial infarction in China.

OBJECTIVE: This study aims to understand the current ST elevated myocardial infarction (STEMI) treatment process in Guangdong Province and explore patient-level and system-level barriers associated with delay in STEMI treatment, so as to provide recommendations for improvement. METHODS: This is a qualitative study. Data were collected using semistructured, face-to-face individual interviews from April 2018 to January 2019. Participants included patients with STEMI, cardiologists and nurses from hospitals, emergency department doctors, primary healthcare providers, local health governors, and coordinators at the emergency medical system (EMS). An inductive thematic analysis was adopted to generate overarching themes and subthemes for potential causes of STEMI treatment delay. The WHO framework for people-centred integrated health services was used to frame recommendations for improving the health system. RESULTS: Thirty-two participants were interviewed. Patient-level barriers included poor knowledge in recognising STEMI symptoms and not calling EMS when symptoms occurred. Limited capacity of health professionals in hospitals below the tertiary level and lack of coordination between hospitals of different levels were identified as the main system-level barriers. Five recommendations were provided: (1) enhance public health education; (2) strengthen primary healthcare workforce; (3) increase EMS capacity; (4) establish an integrated care model; and (5) harness government's responsibilities. CONCLUSIONS: Barriers associated with delay in STEMI treatment were identified at both patient and system levels. The results of this study provide a useful evidence base for future intervention development to improve the quality of STEMI treatment and patient outcomes in China and other countries in a similar situation.

Consensus document for invasive coronary physiologic assessment in Asia-Pacific countries.

BACKGROUND: Currently, invasive physiologic assessment such as fractional flow reserve is widely used worldwide with different adoption rates around the globe. Patient characteristics and physician preferences often differ in the Asia-Pacific (APAC) region with respect to treatment strategy, techniques, lesion complexity, access to coronary physiology and imaging devices, as well as patient management. Thus, there is a need to construct a consensus document on recommendations for use of physiology-guided percutaneous coronary intervention (PCI) in APAC populations. This document serves as an overview of recommendations describing the best practices for APAC populations to achieve more consistent and optimal clinical outcomes. METHODS AND RESULTS: A comprehensive multiple-choice questionnaire was provided to 20 interven- tional cardiologists from 10 countries in the APAC region. Clinical evidence, tips and techniques, and clinical situations for the use of physiology-guided PCI in APAC were reviewed and used to propose key recommendations. There are suggestions to continue to develop evidence for lesion and patient types that will benefit from physiology, develop directions for future research in health economics and local data, develop appropriate use criteria in different countries, and emphasize the importance of education of all stakeholders. A consensus recommendation to enhance the penetration of invasive physiology-based therapy was to adopt the 5E approach: Evidence, Education, Expand hardware, Economics and Expert consensus. CONCLUSIONS: This consensus document and recommendations support interventional fellows and cardiologists, hospital administrators, patients, and medical device companies to build confidence and encourage wider implementation of invasive coronary physiology-guided therapy in the APAC region.

A Simple Modified Framingham Scoring System to Predict Obstructive Coronary Artery Disease.

Development of simple non-invasive risk prediction model would help in early prediction of coronary artery disease (CAD) reducing the burden on public health. This paper demonstrates a risk prediction scoring system to predict obstructive coronary artery disease (OCAD) in CAD patients. A total of 13,082 patients, referred for coronary angiography (CAG) in TRUST trial, were included in the development of a multivariable diagnostic prediction model. External validation of the model used 1009 patients from PRECOMIN study. The occurrence of OCAD was observed in 73.1% and 75.1% patients in TRUST (development) and PRECOMIN study (validation) cohorts, respectively. Good discrimination and calibration were obtained in both development and validation datasets (C-statistics 0.686 and 0.677; Hosmer-Lemeshow χ2 = 5.19, p = 0.74 and χ2 = 8.60, p = 0.38, respectively). The simple risk prediction model and risk scoring system developed on the basis of routine clinical variables showed good performance for estimation of OCAD in relative high-risk patients with suspected CAD.

A simple prediction model to estimate obstructive coronary artery disease.

BACKGROUND: A simple noninvasive model to predict obstructive coronary artery disease (OCAD) may promote risk stratification and reduce the burden of coronary artery disease (CAD). This study aimed to develop pre-procedural, noninvasive prediction models that better estimate the probability of OCAD among patients with suspected CAD undergoing elective coronary angiography (CAG). METHODS: We included 1262 patients, who had reliable Framingham risk variable data, in a cohort without known CAD from a prospective registry of patients referred for elective CAG. We investigated pre-procedural OCAD (≥50% stenosis in at least one major coronary vessel based on CAG) predictors. RESULTS: A total of 945 (74.9%) participants had OCAD. The final modified Framingham scoring (MFS) model consisted of anemia, high-sensitivity C-reactive protein, left ventricular ejection fraction, and five Framingham factors (age, sex, total and high-density lipoprotein cholesterol, and hypertension). Bootstrap method (1000 times) revealed that the model demonstrated a good discriminative power (c statistic, 0.729 ± 0.0225; 95% CI, 0.69-0.77). MFS provided adequate goodness of fit (P = 0.43) and showed better performance than Framingham score (c statistic, 0.703 vs. 0.521; P < 0.001) in predicting OCAD, thereby identifying patients with high risks for OCAD (risk score ≥ 27) with ≥70% predictive value in 68.8% of subjects (range, 37.2-87.3% for low [≤17] and very high [≥41] risk scores). CONCLUSION: Our data suggested that the simple MFS risk stratification tool, which is available in most primary-level clinics, showed good performance in estimating the probability of OCAD in relatively stable patients with suspected CAD; nevertheless, further validation is needed.

Thrombocytopenia as a Preoperative Risk Assessment Tool in Patients With Rheumatic Heart Disease Undergoing Valve Replacement Surgery.

BACKGROUND: Postoperative thrombocytopenia has been reported to be correlated with adverse events, but the prognostic value of baseline thrombocytopenia is unclear. This study was undertaken to evaluate the relationship between preoperative thrombocytopenia and adverse outcomes in patients with rheumatic heart disease who underwent valve replacement surgery. METHODS AND RESULTS: A total of 1789 patients with rheumatic heart disease undergoing valve replacement surgery were consecutively enrolled and postoperatively followed up for 1 year. Patients were stratified on the basis of presence (n=495) or absence (n=1294) of thrombocytopenia (platelet count, <150×109/L), according to hospital admission platelet counts. During the hospitalization period, 69 patients (3.9%) died. The in-hospital all-cause mortality rate was significantly higher in the thrombocytopenic group (6.9% versus 2.7%; P<0.001). Multivariate analyses revealed that thrombocytopenia was independently associated with in-hospital all-cause mortality (odds ratio, 2.21; 95% confidence interval, 1.29-3.80; P=0.004). Platelet counts could predict in-hospital all-cause mortality for patients both with and without previous atrial fibrillation (areas under the curve, 0.708 [P<0.001] and 0.610 [P=0.025], respectively). One-year survival was significantly lower in patients with thrombocytopenia compared with controls (91.3% versus 96.1%; log-rank=14.65; P<0.001). In addition, thrombocytopenia was an independent predictor for postoperative 1-year all-cause mortality in multivariate Cox regression analysis. CONCLUSIONS: Platelet counts, as simple and inexpensive indexes, were reliable to be used as a preoperative risk assessment tool for patients with rheumatic heart disease undergoing valve replacement surgery.

Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis.

BACKGROUND: Quantitative flow ratio (QFR) is a novel angiography-based method for deriving fractional flow reserve (FFR) without pressure wire or induction of hyperemia. The accuracy of QFR when assessed online in the catheterization laboratory has not been adequately examined to date. OBJECTIVES: The goal of this study was to assess the diagnostic performance of QFR for the diagnosis of hemodynamically significant coronary stenosis defined by FFR ≤0.80. METHODS: This prospective, multicenter trial enrolled patients who had at least 1 lesion with a diameter stenosis of 30% to 90% and a reference diameter ≥2 mm according to visual estimation. QFR, quantitative coronary angiography (QCA), and wire-based FFR were assessed online in blinded fashion during coronary angiography and re-analyzed offline at an independent core laboratory. The primary endpoint was that QFR would improve the diagnostic accuracy of coronary angiography such that the lower boundary of the 2-sided 95% confidence interval (CI) of this estimate exceeded 75%. RESULTS: Between June and July 2017, a total of 308 patients were consecutively enrolled at 5 centers. Online QFR and FFR results were both obtained in 328 of 332 interrogated vessels. Patient- and vessel-level diagnostic accuracy of QFR was 92.4% (95% CI: 88.9% to 95.1%) and 92.7% (95% CI: 89.3% to 95.3%), respectively, both of which were significantly higher than the pre-specified target value (p < 0.001). Sensitivity and specificity in identifying hemodynamically significant stenosis were significantly higher for QFR than for QCA (sensitivity: 94.6% vs. 62.5%; difference: 32.0% [p < 0.001]; specificity: 91.7% vs. 58.1%; difference: 36.1% [p < 0.001]). Positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for QFR were 85.5%, 97.1%, 11.4, and 0.06. Offline analysis also revealed that vessel-level QFR had a high diagnostic accuracy of 93.3% (95% CI: 90.0% to 95.7%). CONCLUSIONS: The study met its prespecified primary performance goal for the level of diagnostic accuracy of QFR in identifying hemodynamically significant coronary stenosis. (The FAVOR [Functional Diagnostic Accuracy of Quantitative Flow Ratio in Online Assessment of Coronary Stenosis] II China study]; NCT03191708).