Validation of U.S. mortality prediction models for hospitalized heart failure in the United Kingdom and Japan: Validation of risk models in decompensated heart failure

Aims: Prognostic models for hospitalised heart failure (HHF) were developed predominantly for patients of European origin in the United States of America; it is unclear whether they perform similarly in other health-care systems or for different ethnicities. We sought to validate published prediction models for HHF in the United Kingdom (UK) & Japan.Methods and Results: Patients in the UK (894) and Japan (3,158) were prospectively enrolled and similar in terms of sex (~60% men) and median age (~77 years). Models predicted that British patients would have a higher mortality than Japanese, which was indeed true both for in-hospital [4.8% vs 2.5%] and 180-day [20.7% vs 9.5%] mortality. The model c-statistics for the published/derivation [range 0.70-0.76] and Japanese [range 0.75-0.77] cohorts were similar and higher than for the UK [0.62-0.75] but models consistently over-estimated mortality in Japan. For in-hospital mortality, OPTIMIZE-HF performed best, providing similar discrimination in published/derivation, UK and Japanese cohorts [c-indices: 0.75 (0.74-0.77); 0.75 (0.68 - 0.81) and 0.77 (0.70 - 0.83)], and least over-estimated mortality in Japan. For 180-day mortality, the cstatistics for ASCEND-HF were similar in published/derivation [0.70] and UK [0.69 (0.64 - 0.74)] cohorts but higher in Japan [0.75 (0.71 - 0.79)]; calibration was good in the UK but again over-estimated mortality in Japan.Conclusion: Calibration of published prediction models appear moderately accurate and unbiased when applied to British patients but consistently overestimate mortality in Japan. Identifying the reason why patients in Japan have a better than predicted prognosis is of great interest

Mortality after admission for heart failure in the UK compared with Japan

Objective Mortality amongst patients hospitalised for heart failure (HHF) in Western and Asian countries may differ, but this has not been investigated using individual patient-level data (IPLD). We sought to remedy this through rigorous statistical analysis of HHF registries and variable selection from a systematic literature review.Methods and results IPLD from registries of HHF in Japan (n=3781) and the UK (n=894) were obtained. A systematic literature review identified 23 models for predicting outcome of HHF. Five variables appearing in 10 or more reports were strongly related to prognosis (systolic blood pressure, serum sodium concentration, age, blood urea nitrogen and creatinine). To compare mortality in the UK and Japan, variables were imputed in a propensity model using inverse probability of treatment weighting (IPTW) and IPTW with logistic regression (doubly robust IPTW). Overall, patients in the UK were sicker and in-patient and post-discharge mortalities were greater, suggesting that the threshold for hospital admission was higher. Covariate-adjusted in-hospital mortality was similar in the UK and Japan (IPTW OR: 1.14, 95% CI 0.70 to 1.86), but 180-day postdischarge mortality was substantially higher in the UK (doubly robust IPTW OR: 2.33, 95% CI 1.58 to 3.43).Conclusions Despite robust methods to adjust for differences in patient characteristics and disease severity, HHF patients in the UK have roughly twice the mortality at 180 days compared with those in Japan. Similar analyses should be done using other data sets and in other countries to determine the consistency of these findings and identify factors that might inform healthcare policy and improve outcomes

Risk of cardiovascular events and death associated with initiation of SGLT2 inhibitors compared with DPP-4 inhibitors:an analysis from the CVD-REAL 2 multinational cohort study

Background Cardiovascular outcome trials have shown cardiovascular benefit with sodium-glucose co-transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes, whereas dipeptidyl peptidase-4 (DPP-4) inhibitors have not shown an effect. We aimed to address knowledge gaps regarding the comparative effectiveness of SGLT2 inhibitor use in clinical practice (with DPP-4 inhibitor use as an active comparator) across a range of cardiovascular risks and in diverse geographical settings. Methods In this comparative cohort study, we used data from clinical practice from 13 countries in the Asia-Pacific, Middle East, European, and North American regions to assess the risk of cardiovascular events and death in adult patients with type 2 diabetes newly initiated on SGLT2 inhibitors compared with those newly initiated on DPP-4 inhibitors. De-identified health records were used to select patients who were initiated on these drug classes between Dec 1, 2012, and May 1, 2016, with follow-up until Dec 31, 2014, to Nov 30, 2017 (full range; dates varied by country). Non-parsimonious propensity scores for SGLT2 inhibitor initiation were developed for each country and patients who were initiated on an SGLT2 inhibitor were matched with those who were initiated on a DPP-4 inhibitor in a 1:1 ratio. Outcomes assessed were hospitalisation for heart failure, all-cause death, myocardial infarction, and stroke. Hazard ratios (HRs) were estimated by country and then pooled in a weighted meta-analysis. Findings Following propensity score matching, 193 124 new users of SGLT2 inhibitors and 193 124 new users of DPP-4 inhibitors were included in the study population. Participants had a mean age of 58 years (SD 12.2), 170 335 (44.1%) of 386 248 were women, and 111933 (30.1%) of 372 262 had established cardiovascular disease. Initiation of an SGLT2 inhibitor versus a DPP-4 inhibitor was associated with substantially lower risks of hospitalisation for heart failure (HR 0.69, 95% CI 0. 61-0. 77; p Interpretation In this large, international, observational study, initiation of SGLT2 inhibitors versus DPP-4 inhibitors was associated with lower risks of heart failure, death, myocardial infarction, and stroke, providing further support for the cardiovascular benefits associated with use of SGLT2 inhibitors in patients with type 2 diabetes. Copyright (C) 2020 Elsevier Ltd. All rights reserved

CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in 2018

While primary percutaneous coronary intervention (PCI) has significantly contributed to improve the mortality in patients with ST segment elevation myocardial infarction even in cardiogenic shock, primary PCI is a standard of care in most of Japanese institutions. Whereas there are high numbers of available facilities providing primary PCI in Japan, there are no clear guidelines focusing on procedural aspect of the standardized care. Whilst updated guidelines for the management of acute myocardial infarction were recently published by European Society of Cardiology, the following major changes are indicated; (1) radial access and drug-eluting stent over bare metal stent were recommended as Class I indication, and (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. Although the primary PCI is consistently recommended in recent and previous guidelines, the device lag from Europe, the frequent usage of coronary imaging modalities in Japan, and the difference in available medical therapy or mechanical support may prevent direct application of European guidelines to Japanese population. The Task Force on Primary Percutaneous Coronary Intervention of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) has now proposed the expert consensus document for the management of acute myocardial infarction focusing on procedural aspect of primary PCI

Prosthesis-patient mismatch affects long-term survival after mechanical valve replacement

Objective: We sought to examine the relationship between the degree of prosthesis-patient mismatch and long-term survival after mechanical aortic valve replacement.Methods: Prospectively collected long-term follow-up data from 469 consecutive patients who underwent aortic valve replacement between 1995 and 1998 were reviewed. The indexed effective orifice area was derived from the reference normal values of effective orifice area divided by the patient\u27s body surface area. Outcome was stratified according to the severity of prosthesis-patient mismatch: moderate mismatch was defined as 0.65 to 0.85 cm(2)/m(2) and severe mismatch as less than 0.65 cm(2)/m(2). The Cox proportional-hazards model with propensity score adjustment was used to adjust for the observed differences in baseline characteristics between the mismatch groups.Results: The degree of prosthesis-patient mismatch was minimal in 57% of patients, moderate in 39%, and severe in 4%. Predictors of clinically significant mismatch included small aortic valve sizes (19 and 21 mm), obesity, age greater than 65 years, and class III or IV heart failure. During a median follow-up period of approximately 7.9 years, overall survival was 77% in patients with minimal mismatch, 63% in those with moderate mismatch, and only 47% in those with severe mismatch (P \u3c .001). Moderate or severe mismatch was a significant predictor of poorer survival (hazard ratio, 1.6; 95% confidence interval, 1.4-2.3; P \u3c .01), even after adjustment for all significant clinical predictors (ie, propensity score; hazard ratio, 1.2; 95% confidence interval, 1.0-1.5; P = .05).Conclusions: In a large aortic valve surgery population, prosthesis-patient mismatch occurred in 43% of patients, and those with significant mismatch had worse long-term outcomes than those with minimal mismatch

Prosthesis-patient mismatch affects long-term survival after mechanical valve replacement

Objective: We sought to examine the relationship between the degree of prosthesis-patient mismatch and long-term survival after mechanical aortic valve replacement.Methods: Prospectively collected long-term follow-up data from 469 consecutive patients who underwent aortic valve replacement between 1995 and 1998 were reviewed. The indexed effective orifice area was derived from the reference normal values of effective orifice area divided by the patient\u27s body surface area. Outcome was stratified according to the severity of prosthesis-patient mismatch: moderate mismatch was defined as 0.65 to 0.85 cm(2)/m(2) and severe mismatch as less than 0.65 cm(2)/m(2). The Cox proportional-hazards model with propensity score adjustment was used to adjust for the observed differences in baseline characteristics between the mismatch groups.Results: The degree of prosthesis-patient mismatch was minimal in 57% of patients, moderate in 39%, and severe in 4%. Predictors of clinically significant mismatch included small aortic valve sizes (19 and 21 mm), obesity, age greater than 65 years, and class III or IV heart failure. During a median follow-up period of approximately 7.9 years, overall survival was 77% in patients with minimal mismatch, 63% in those with moderate mismatch, and only 47% in those with severe mismatch (P \u3c .001). Moderate or severe mismatch was a significant predictor of poorer survival (hazard ratio, 1.6; 95% confidence interval, 1.4-2.3; P \u3c .01), even after adjustment for all significant clinical predictors (ie, propensity score; hazard ratio, 1.2; 95% confidence interval, 1.0-1.5; P = .05).Conclusions: In a large aortic valve surgery population, prosthesis-patient mismatch occurred in 43% of patients, and those with significant mismatch had worse long-term outcomes than those with minimal mismatch

Long-term clinical outcome of coronary artery stenting or coronary artery bypass grafting in patients with multiple-vessel disease

Objective: Recent large-scale observational studies have shown better outcomes after coronary artery bypass grafting than after angioplasty or stenting in patients with multiple-vessel disease. The time frames of these studies, however, include periods of varying behavior with respect to patient selection, stent technique and design, and medical therapy. Our objective was to examine long-term outcomes of coronary stenting and coronary artery bypass grafting, including those performed in the contemporary era of aggressive medical therapy.Methods: We examined in-hospital and long-term follow-up data from consecutive patients with multivessel coronary artery disease who underwent isolated initial revascularization by coronary stenting or coronary artery bypass grafting between 1995 and 2003. Cox proportional hazards modeling with propensity scoring and propensity-based case matching were used to compare long-term survival and correct for baseline differences between the populations.Results: A total of 6847 patients were studied (stenting 3917, coronary artery bypass grafting 2930). Each patient had 1 to 9 years of follow-up (median 3.5 years). Unadjusted long-term mortalities were similar for coronary artery bypass grafting and stenting (hazard ratio 1.1, 95% confidence interval 0.9-1.2, P = .21). Matched comparison of 3488 patients (1856 in each group) with similar likelihoods of undergoing coronary stenting or coronary artery bypass grafting, however, suggested that coronary artery bypass grafting provided better long-term survival (hazard ratio 0.7, 95% confidence interval 0.6-0.9; P = .004).Conclusion: During a 9-year period, in physician-selected patients with favorable demographic characteristics for both revascularization procedures, coronary artery bypass grafting was associated with better long-term survival than stent-assisted angioplasty

Long-term clinical outcome of coronary artery stenting or coronary artery bypass grafting in patients with multiple-vessel disease

Objective: Recent large-scale observational studies have shown better outcomes after coronary artery bypass grafting than after angioplasty or stenting in patients with multiple-vessel disease. The time frames of these studies, however, include periods of varying behavior with respect to patient selection, stent technique and design, and medical therapy. Our objective was to examine long-term outcomes of coronary stenting and coronary artery bypass grafting, including those performed in the contemporary era of aggressive medical therapy.Methods: We examined in-hospital and long-term follow-up data from consecutive patients with multivessel coronary artery disease who underwent isolated initial revascularization by coronary stenting or coronary artery bypass grafting between 1995 and 2003. Cox proportional hazards modeling with propensity scoring and propensity-based case matching were used to compare long-term survival and correct for baseline differences between the populations.Results: A total of 6847 patients were studied (stenting 3917, coronary artery bypass grafting 2930). Each patient had 1 to 9 years of follow-up (median 3.5 years). Unadjusted long-term mortalities were similar for coronary artery bypass grafting and stenting (hazard ratio 1.1, 95% confidence interval 0.9-1.2, P = .21). Matched comparison of 3488 patients (1856 in each group) with similar likelihoods of undergoing coronary stenting or coronary artery bypass grafting, however, suggested that coronary artery bypass grafting provided better long-term survival (hazard ratio 0.7, 95% confidence interval 0.6-0.9; P = .004).Conclusion: During a 9-year period, in physician-selected patients with favorable demographic characteristics for both revascularization procedures, coronary artery bypass grafting was associated with better long-term survival than stent-assisted angioplasty