Publications by authors named "Robert McKelvie"

179 Publications

CCS/CHFS Heart Failure Guidelines Update: Defining a New Pharmacologic Standard of Care for Heart Failure With Reduced Ejection Fraction.

Can J Cardiol 2021 Apr;37(4):531-546

St Mary's General Hospital, McMaster University, Kitchener, Ontario, Canada.

In this update of the Canadian Cardiovascular Society heart failure (HF) guidelines, we provide comprehensive recommendations and practical tips for the pharmacologic management of patients with HF with reduced ejection fraction (HFrEF). Since the 2017 comprehensive update of the Canadian Cardiovascular Society guidelines for the management of HF, substantial new evidence has emerged that has informed the care of these patients. In particular, we focus on the role of novel pharmacologic therapies for HFrEF including angiotensin receptor-neprilysin inhibitors, sinus node inhibitors, sodium glucose transport 2 inhibitors, and soluble guanylate cyclase stimulators in conjunction with other long established HFrEF therapies. Updated recommendations are also provided in the context of the clinical setting for which each of these agents might be prescribed; the potential value of each therapy is reviewed, where relevant, for chronic HF, new onset HF, and for HF hospitalization. We define a new standard of pharmacologic care for HFrEF that incorporates 4 key therapeutic drug classes as standard therapy for most patients: an angiotensin receptor-neprilysin inhibitor (as first-line therapy or after angiotensin converting enzyme inhibitor/angiotensin receptor blocker titration); a β-blocker; a mineralocorticoid receptor antagonist; and a sodium glucose transport 2 inhibitor. Additionally, many patients with HFrEF will have clinical characteristics for which we recommended other key therapies to improve HF outcomes, including sinus node inhibitors, soluble guanylate cyclase stimulators, hydralazine/nitrates in combination, and/or digoxin. Finally, an approach to management that integrates prioritized pharmacologic with nonpharmacologic and invasive therapies after a diagnosis of HFrEF is highlighted.
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http://dx.doi.org/10.1016/j.cjca.2021.01.017DOI Listing
April 2021

Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction.

Clin Res Cardiol 2020 Dec 10. Epub 2020 Dec 10.

British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.

Background: Sudden death (SD) and pump failure death (PFD) are leading modes of death in heart failure and preserved ejection fraction (HFpEF). Risk stratification for mode-specific death may aid in patient enrichment for new device trials in HFpEF.

Methods: Models were derived in 4116 patients in the Irbesartan in Heart Failure with Preserved Ejection Fraction trial (I-Preserve), using competing risks regression analysis. A series of models were built in a stepwise manner, and were validated in the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM)-Preserved and Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trials.

Results: The clinical model for SD included older age, men, lower LVEF, higher heart rate, history of diabetes or myocardial infarction, and HF hospitalization within previous 6 months, all of which were associated with a higher SD risk. The clinical model predicting PFD included older age, men, lower LVEF or diastolic blood pressure, higher heart rate, and history of diabetes or atrial fibrillation, all for a higher PFD risk, and dyslipidaemia for a lower risk of PFD. In each model, the observed and predicted incidences were similar in each risk subgroup, suggesting good calibration. Model discrimination was good for SD and excellent for PFD with Harrell's C of 0.71 (95% CI 0.68-0.75) and 0.78 (95% CI 0.75-0.82), respectively. Both models were robust in external validation. Adding ECG and biochemical parameters, model performance improved little in the derivation cohort but decreased in validation. Including NT-proBNP substantially increased discrimination of the SD model, and simplified the PFD model with marginal increase in discrimination.

Conclusions: The clinical models can predict risks for SD and PFD separately with good discrimination and calibration in HFpEF and are robust in external validation. Adding NT-proBNP further improved model performance. These models may help to identify high-risk individuals for device intervention in future trials.

Clinical Trial Registration: I-Preserve: ClinicalTrials.gov NCT00095238; TOPCAT: ClinicalTrials.gov NCT00094302; CHARM-Preserved: ClinicalTrials.gov NCT00634712.
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http://dx.doi.org/10.1007/s00392-020-01786-8DOI Listing
December 2020

Sex, Depression, and More in Cardiac Rehabilitation.

Can J Cardiol 2021 Mar 5;37(3):357-358. Epub 2020 Dec 5.

St Joseph's Health Care London, London, Ontario, Canada; Western University, London, Ontario, Canada.

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http://dx.doi.org/10.1016/j.cjca.2020.12.001DOI Listing
March 2021

Optimal Usage of Sacubitril/Valsartan for the Treatment of Heart Failure: The Importance of Optimizing Heart Failure Care in Canada.

CJC Open 2020 Sep 5;2(5):321-327. Epub 2020 Apr 5.

St Joseph's Health Care London, London, Ontario, Canada.

Background: Heart failure (HF) with reduced ejection fraction represents approximately 50% of the 600,000 Canadians currently living with HF and over 90,000 new cases diagnosed each year. The angiotensin receptor neprilysin inhibitor, sacubitril/valsartan, demonstrated superior efficacy in reducing cardiovascular death and HF hospitalization over standard of care therapy.

Methods: The potential magnitude of benefit in Canada with respect to preventing or postponing deaths and reducing hospitalizations resulting from its optimal implementation in patients with HF with an ejection fraction <40% was estimated based on published sources.

Results: Of the potentially eligible 225,562 patients, this would amount to the prevention of 4699 cardiovascular deaths and first HF hospitalizations, 3698 thirty-day HF readmissions, and 2820 deaths due to all-cause mortality. The number of patients receiving sacubitril/valsartan nationally in 2018 was 27,267. This represents approximately 12% of the calculated eligible population for this therapy in Canada.

Conclusions: The findings from this analysis suggest that a substantial number of deaths, hospitalizations, and HF readmissions could potentially be avoided by optimal usage of sacubitril/valsartan therapy in Canada. This emphasizes the importance of rapidly and appropriately implementing evidence-based medications into routine clinical practice, to achieve the best possible outcomes for our patients with HF and to reduce the high burden and cost of HF in Canada.
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http://dx.doi.org/10.1016/j.cjco.2020.03.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499363PMC
September 2020

The Status of Specialized Ambulatory Heart Failure Care in Canada: A Joint Canadian Heart Failure Society and Canadian Cardiovascular Society Heart Failure Guidelines Survey.

CJC Open 2020 May 7;2(3):151-160. Epub 2020 Mar 7.

Memorial University, St John's, Newfoundland, Canada.

This joint Canadian Heart Failure Society and the CCS Heart Failure guidelines report has been developed to provide a pan-Canadian snapshot of the current state of clinic-based ambulatory heart failure (HF) care in Canada with specific reference to elements and processes of care associated with quality and high performing health systems. It includes the viewpoints of persons with lived experience, patient care providers, and administrators. It is imperative to build on the themes identified in this survey, through engaging all health care professionals, to develop integrated and shared care models that will allow better patient outcomes. Several patient and organizational barriers to care were identified in this survey, which must inform the development of regional care models and pragmatic solutions to improve transitions for this patient population. Unfortunately, we were unsuccessful in incorporating the perspectives of primary care providers and internal medicine specialists who provide the majority of HF care in Canada, which in turn limits our ability to comment on strategies for capacity building outside the HF clinic setting. These considerations must be taken into account when interpreting our findings. Engaging all HF care providers, to build on the themes identified in this survey, will be an important next step in developing integrated and shared care models known to improve patient outcomes.
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http://dx.doi.org/10.1016/j.cjco.2020.03.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242502PMC
May 2020

Effect of a formalised discharge process which includes electronic delivery of prescriptions to pharmacies on the incidence of delayed prescription retrieval.

BMJ Open Qual 2020 05;9(2)

Division of Cardiology, London Health Sciences Centre and St. Joseph's Health Care, London, Ontario, Canada.

Background: Lack of prescription adherence after discharge from the inpatient hospital setting is a barrier to the delivery of optimal patient care. Non-adherence to medication for cardiac diseases can lead to substantial morbidity, mortality and healthcare costs. Electronic delivery of prescriptions by fax is a potential method of improving patient satisfaction and reducing pharmacy wait times.

Methods: This study was completed in the cardiology inpatient wards at a hospital in London, Ontario, Canada. 'Delayed prescription retrieval' was defined as the retrieval of a prescribed medication by a patient from their local pharmacy after the documented calendar day of discharge. The current discharge process on the cardiology wards was assessed and an initial monitoring period of study participants was completed to determine the baseline delayed prescription retrieval rate (preintervention group). A formalised discharge process, which included electronic delivery of prescriptions to pharmacies by fax, was implemented for study participants (postintervention group). The rate of delayed prescription retrieval was assessed in both groups.

Results: 15 of 42 patients (35.7%) in the preintervention group and 9 of 72 (14.3%) in the postintervention group had delayed prescription retrieval suggesting relative and absolute risk reductions of 65% and 23.2% (p=0.0045). Of the participants with delayed prescription retrieval, 100% in the preintervention group and 77.8% in the postintervention group were due a new prescribed medication on the day of discharge.

Conclusions: Patients who experienced a formalised discharge process, which included electronic delivery of prescriptions by fax, at the time of discharge from cardiac inpatient care had a lower rate of delayed prescription retrieval. Future studies are required to examine the impact of formal discharge processes on patient morbidity and mortality.
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http://dx.doi.org/10.1136/bmjoq-2019-000849DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228567PMC
May 2020

Covariate adjusted reanalysis of the I-Preserve trial.

Clin Res Cardiol 2020 Nov 25;109(11):1358-1365. Epub 2020 Mar 25.

BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.

Background: The CHARM-Preserved trial suggested that the renin-angiotensin system (RAS) inhibitor candesartan might have been beneficial in heart failure with preserved ejection fraction (HFpEF); however, this hypothesis was not supported by the findings of I-Preserve with irbesartan.

Aims: To re-analyse the results of I-Preserve, adjusting for imbalances in baseline variables that may have influenced the trial outcomes.

Methods: Cox proportional hazards models with covariate adjustment for baseline variables, including age, sex, medical history, physiological and laboratory variables.

Results: In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). The prespecified analysis of this outcome, stratifying for the use of ACEi at baseline, gave a hazard ratio (HR) of 0.95 (95% confidence interval, 0.86-1.05); p = 0.35. Adjusting the effect of treatment for key prognostic baseline variables, gave a HR of 0.89 (0.80-0.99); p = 0.033. Similar findings were observed for the composite of cardiovascular death or HF hospitalization.

Conclusion: Adjusting for imbalances in baseline variables that influence outcomes (or the response to therapy or both) can improve the power around the estimate of the effect of treatment and may alter its statistical significance. Along with the CHARM-Preserved results, these findings suggest that angiotensin-receptor blockers may have a modest effect in HFpEF.
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http://dx.doi.org/10.1007/s00392-020-01632-xDOI Listing
November 2020

An Update on the Development and Feasibility Assessment of Canadian Quality Indicators for Atrial Fibrillation and Atrial Flutter.

CJC Open 2019 Jul 8;1(4):198-205. Epub 2019 Jun 8.

Department of Medicine, London Heart Institute, University of Western Ontario, London, Ontario, Canada.

Background: In 2010, the Canadian Cardiovascular Society Atrial Fibrillation/Atrial Flutter (AF/AFL) quality indicator (QI) working group was established to develop QIs and assess feasibility of measurement. After extensive review, 3 priority QIs were selected. However, none were measurable at a national level.

Methods: The working group reconvened in 2017 to review the relevance of previously proposed QIs, identify opportunities to develop new QIs, and propose an initial strategy for measuring and reporting.

Results: Two additional priority QIs were added to the previous 3: proportion of patients with nonvalvular (NV) AF/AFL sorted by stroke risk stratum and annual rate of hospitalization for a new heart failure diagnosis. An environmental scan was undertaken to determine the potential of existing databases to provide national and provincial estimates. On the basis of validated administrative codes, the Canadian Institute for Health Information discharge abstract database can be used for inpatients. In collaboration with the Canadian Primary Care Sentinel Surveillance Network, 2 of the 5 QIs can be assessed in outpatients (patients with NVAF/AFL sorted by stroke risk stratum and high risk for stroke NVAF/AFL receiving oral anticoagulation). Stroke prevention therapy can be further measured in selected provinces with linked databases including prescriptions.

Conclusions: This first step could provide a better initial understanding of the quality of AF/AFL care in Canada, but important gaps in the meaningful measurement of QIs remain. The AF/AFL QI working group has limited capacity to make progress without national level leadership and the resources to support data aggregation, data analysis, and pan-Canadian reporting.
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http://dx.doi.org/10.1016/j.cjco.2019.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7063642PMC
July 2019

Therapies for Advanced Heart Failure Patients Ineligible for Heart Transplantation: Beyond Pharmacotherapy.

Can J Cardiol 2020 02 20;36(2):234-243. Epub 2019 Nov 20.

St Joseph's Health Care London, London, Ontario, Canada; Western University, London, Ontario, Canada. Electronic address:

Globally, there are ∼ 26 million people living with heart failure (HF), 50% of them with reduced ejection fraction, costing countries billions of dollars each year. Improvements in treatment of cardiovascular diseases, including advanced HF, have allowed an unprecedented number of patients to survive into old age. Despite these advances, patients with HF deteriorate and often require advanced therapies. As the proportion of elderly patients in the population increases, there will be an increasing number of patients to be evaluated for advanced therapies and an increasing number that do not qualify for, won't be considered for, or decline orthotopic heart transplantation. The purpose of this article is to review the benefits of palliative care (PC), exercise-based cardiac rehabilitation (ExCR), device therapy (cardiac resynchronization therapy and mitral clip), and mechanical circulatory support (MCS) in advanced HF patients who are transplant ineligible. PC interventions should be introduced early in the course of a patient's diagnosis to manage symptoms, address goals of care, and improve patient-centered outcomes. Further improvement in health-related quality of life as well as functional capacity can be achieved safely in patients with advanced HF through patient participation in ExCR. Device therapy and MCS can reduce HF hospitalizations and improve survival. In fact, early survival with MCS approaches that of heart transplantation. Despite their being transplant ineligible, there are a variety of treatment options available to patients to improve their quality of life, decrease hospitalizations, and potentially improve mortality.
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http://dx.doi.org/10.1016/j.cjca.2019.11.012DOI Listing
February 2020

CCS/CHFS Heart Failure Guidelines: Clinical Trial Update on Functional Mitral Regurgitation, SGLT2 Inhibitors, ARNI in HFpEF, and Tafamidis in Amyloidosis.

Can J Cardiol 2020 02;36(2):159-169

Memorial University, St John's, Newfoundland and Labrador, Canada.

In this update, we focus on selected topics of high clinical relevance for health care providers who treat patients with heart failure (HF), on the basis of clinical trials published after 2017. Our objective was to review the evidence, and provide recommendations and practical tips regarding the management of candidates for the following HF therapies: (1) transcatheter mitral valve repair in HF with reduced ejection fraction; (2) a novel treatment for transthyretin amyloidosis or transthyretin cardiac amyloidosis; (3) angiotensin receptor-neprilysin inhibition in patients with HF and preserved ejection fraction (HFpEF); and (4) sodium glucose cotransport inhibitors for the prevention and treatment of HF in patients with and without type 2 diabetes. We emphasize the roles of optimal guideline-directed medical therapy and of multidisciplinary teams when considering transcatheter mitral valve repair, to ensure excellent evaluation and care of those patients. In the presence of suggestive clinical indices, health care providers should consider the possibility of cardiac amyloidosis and proceed with proper investigation. Tafamidis is the first agent shown in a prospective study to alter outcomes in patients with transthyretin cardiac amyloidosis. Patient subgroups with HFpEF might benefit from use of sacubitril/valsartan, however, further data are needed to clarify the effect of this therapy in patients with HFpEF. Sodium glucose cotransport inhibitors reduce the risk of incident HF, HF-related hospitalizations, and cardiovascular death in patients with type 2 diabetes and cardiovascular disease. A large clinical trial recently showed that dapagliflozin provides significant outcome benefits in well treated patients with HF with reduced ejection fraction (left ventricular ejection fraction ≤ 40%), with or without type 2 diabetes.
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http://dx.doi.org/10.1016/j.cjca.2019.11.036DOI Listing
February 2020

DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care.

BMJ Open 2019 12 15;9(12):e030301. Epub 2019 Dec 15.

Hamilton Niagara Haldimand Brant Local Health Integration Network, Hamilton, Ontario, Canada.

Introduction: Home care clients are increasingly medically complex, have limited access to effective chronic disease management and have very high emergency department (ED) visitation rates. There is a need for more appropriate and targeted supportive chronic disease management for home care clients. We aim to evaluate the effectiveness and preliminary cost effectiveness of a targeted, person-centred cardiorespiratory management model.

Methods And Analysis: The Detection of Indicators and Vulnerabilities of Emergency Room Trips (DIVERT) - Collaboration Action Research and Evaluation (CARE) trial is a pragmatic, cluster-randomised, multicentre superiority trial of a flexible multicomponent cardiorespiratory management model based on the best practice guidelines. The trial will be conducted in partnership with three regional, public-sector, home care providers across Canada. The primary outcome of the trial is the difference in time to first unplanned ED visit (hazard rate) within 6 months. Additional secondary outcomes are to identify changes in patient activation, changes in cardiorespiratory symptom frequencies and cost effectiveness over 6 months. We will also investigate the difference in the number of unplanned ED visits, number of inpatient hospitalisations and changes in health-related quality of life. Multilevel proportional hazard and generalised linear models will be used to test the primary and secondary hypotheses. Sample size simulations indicate that enrolling 1100 home care clients across 36 clusters (home care caseloads) will yield a power of 81% given an HR of 0.75.

Ethics And Dissemination: Ethics approval was obtained from the Hamilton Integrated Research Ethics Board as well as each participating site's ethics board. Results will be submitted for publication in peer-reviewed journals and for presentation at relevant conferences. Home care service partners will also be informed of the study's results. The results will be used to inform future support strategies for older adults receiving home care services.

Trial Registration Number: NCT03012256.
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http://dx.doi.org/10.1136/bmjopen-2019-030301DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924743PMC
December 2019

Sex-Related Differences in Heart Failure With Preserved Ejection Fraction.

Circ Heart Fail 2019 12 9;12(12):e006539. Epub 2019 Dec 9.

BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (P.D., R.R., R.T.C., L.S., P.S.J., M.C.P., J.J.V.M.).

Background: To describe characteristics and outcomes in women and men with heart failure with preserved ejection fraction.

Methods: Baseline characteristics (including biomarkers and quality of life) and outcomes (primary outcome: composite of first heart failure hospitalization or cardiovascular death) were compared in 4458 women and 4010 men enrolled in CHARM-Preserved (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity) (EF≥45%), I-Preserve (Irbesartan in heart failure with Preserved ejection fraction), and TOPCAT-Americas (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial).

Results: Women were older and more often obese and hypertensive but less likely to have coronary artery disease or atrial fibrillation. Women had more symptoms and signs of congestion and worse quality of life. Despite this, the risk of the primary outcome was lower in women (hazard ratio, 0.80 [95% CI, 0.73-0.88]), as was the risk of cardiovascular death (hazard ratio, 0.70 [95% CI, 0.62-0.80]), but there was no difference in the rate for first hospitalization for heart failure (hazard ratio, 0.92 [95% CI, 0.82-1.02]). The lower risk of cardiovascular death in women, compared with men, was in part explained by a substantially lower risk of sudden death (hazard ratio, 0.53 [0.43-0.65]; <0.001). E/A ratio was lower in women (1.1 versus 1.2).

Conclusions: There are significant differences between women and men with heart failure with preserved ejection fraction. Despite worse symptoms, more congestion, and lower quality of life, women had similar rates of hospitalization and better survival than men. Their risk of sudden death was half that of men.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00853658, NCT01035255.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006539DOI Listing
December 2019

The Role of Physicians in the Era of Big Data.

Can J Cardiol 2020 01 1;36(1):19-21. Epub 2019 Oct 1.

Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.

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http://dx.doi.org/10.1016/j.cjca.2019.09.018DOI Listing
January 2020

Long-term Enrollment in Cardiac Rehabilitation Benefits Cardiorespiratory Fitness and Skeletal Muscle Strength in Men With Cardiovascular Disease.

Can J Cardiol 2019 10 21;35(10):1359-1365. Epub 2019 May 21.

School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada. Electronic address:

Background: Despite known associations between fitness and recurrent cardiovascular events, changes in cardiorespiratory fitness (CRF) and muscle strength with long-term cardiac rehabilitation (CR) have not been extensively examined. The objectives of this study were to (1) examine changes in CRF and muscle strength associated with long-term CR program enrollment in men, and (2) compare these changes to previously published rates of decline (2.0% per year for CRF and 2.36% per year for muscle strength in healthy age-matched individuals).

Methods: Data were extracted from the program charts of 160 men (64 ± 9 years) who were enrolled ≥ 1 year in a maintenance-phase CR program and who completed ≥ 2 exercise tests. CRF was represented by peak oxygen consumption (VO, mL/min/kg). The skeletal muscle strength was assessed using 1-repetition maximum tests for chest press, seated row, and knee extension. Mixed model analyses with polynomial functions were used to determine changes in CRF (up to 5.5 years) and muscle strength (up to 10 years).

Results: CRF increased nonlinearly up to 3 years (range, 0.33%-3.23% per year) and then declined nonlinearly to the 5.5-year endpoint (range, 1.03%-2.59% per year). Chest press and seated row strength declined at < 1% per year over 10 years, whereas knee extension increased nonlinearly by 0.18%-1.40% per year from baseline until 4 years and then declined nonlinearly at 1.00%-3.58% per year until the 10-year endpoint. All declines were similar to literature rates.

Conclusions: The results indicate that significant health benefits are associated with maintenance-phase CR programs for men. Enrollment was associated with preserved CRF and lower body muscle strength for 3-4 years.
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http://dx.doi.org/10.1016/j.cjca.2019.05.018DOI Listing
October 2019

Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction.

J Am Coll Cardiol 2019 08;74(5):601-612

BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address:

Background: Although heart failure with preserved ejection fraction (HFpEF) is considered a disease of the elderly, younger patients are not spared from this syndrome.

Objectives: This study therefore investigated the associations among age, clinical characteristics, and outcomes in patients with HFpEF.

Methods: Using data on patients with left ventricular ejection fraction ≥45% from 3 large HFpEF trials (TOPCAT [Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function], I-PRESERVE [Irbesartan in Heart Failure With Preserved Systolic Function], and CHARM Preserved [Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity]), patients were categorized according to age: ≤55 years (n = 522), 56 to 64 years (n = 1,679), 65 to 74 years (n = 3,405), 75 to 84 years (n = 2,464), and ≥85 years (n = 398). This study compared clinical and echocardiographic characteristics, as well as mortality and hospitalization rates, mode of death, and quality of life across age categories.

Results: Younger patients (age ≤55 years) with HFpEF were more often obese, nonwhite men, whereas older patients with HFpEF were more often white women with a higher prevalence of atrial fibrillation, hypertension, and chronic kidney disease (eGFR <60 ml/min/1.73 m). Despite fewer comorbidities, younger patients had worse quality of life compared with older patients (age ≥85 years). Compared with patients age ≤55 years, patients age ≥85 years had higher mortality (hazard ratio: 6.9; 95% confidence interval: 4.2 to 11.4). However, among patients who died, sudden death was, proportionally, the most common mode of death (p < 0.001) in patients age ≤55 years. In contrast, older patients (age ≥85 years) died more often from noncardiovascular causes (34% vs. 20% in patients age ≤55 years; p < 0.001).

Conclusions: Compared with the elderly, younger patients with HFpEF were less likely to be white, were more frequently obese men, and died more often of cardiovascular causes, particularly sudden death. In contrast, elderly patients with HFpEF had more comorbidities and died more often from noncardiovascular causes. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302; Irbesartan in Heart Failure With Preserved Systolic Function [I-PRESERVE]; NCT00095238; Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM Preserved]; NCT00634712).
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http://dx.doi.org/10.1016/j.jacc.2019.05.052DOI Listing
August 2019

Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction.

Eur J Heart Fail 2019 08 4;21(8):974-984. Epub 2019 Jul 4.

BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.

Aims: Insulin causes sodium retention and hypoglycaemia and its use is associated with worse outcomes in heart failure (HF) with reduced ejection fraction. We have investigated whether this is also the case in HF with preserved ejection fraction (HFpEF).

Methods And Results: We examined the association between diabetes/diabetes treatments and the risk of the primary composite of cardiovascular death or HF hospitalization, as well as other outcomes in adjusted analyses in CHARM-Preserved (left ventricular ejection fraction ≥ 45%), I-Preserve and TOPCAT (Americas) pooled. Of 8466 patients, 2653 (31%) had diabetes, including 979 (37%) receiving insulin. Patients receiving insulin were younger, had a higher body mass index, prevalence of ischaemic aetiology, N-terminal pro-B-type natriuretic peptide and use of diuretics, worse New York Heart Association class and signs and symptoms, and worse quality of life and renal function, compared to patients with diabetes not on insulin. Among the 1398 patients with echocardiographic data, insulin use was associated with higher left ventricular end-diastolic pressure and more diastolic dysfunction than in other participants. The primary outcome occurred at a rate of 6.3 per 100 patient-years in patients without diabetes, and 10.2 and 17.1 per 100 patient-years in diabetes patients without and with insulin use, respectively [fully adjusted hazard ratio (aHR) insulin-treated diabetes vs. other diabetes: 1.41, 95% confidence interval (CI) 1.23-1.63, P < 0.001]. The adjusted HR is 1.67 (95% CI 1.20-2.32, p = 0.002) for sudden death (insulin-treated diabetes vs. other diabetes).

Conclusions: Insulin use is associated with poor outcomes in HFpEF. Although we cannot conclude a causal association, the safety of insulin and alternative glucose-lowering treatments in HF needs to be evaluated in clinical trials.
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http://dx.doi.org/10.1002/ejhf.1535DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7079555PMC
August 2019

Prior Pacemaker Implantation and Clinical Outcomes in Patients With Heart Failure and Preserved Ejection Fraction.

JACC Heart Fail 2019 05 10;7(5):418-427. Epub 2019 Apr 10.

British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom. Electronic address:

Objectives: This study examined the relationship between prior pacemaker implantation and clinical outcomes in patients with heart failure with preserved ejection fraction (HFpEF).

Background: Conventional right ventricular pacing causes electrical and mechanical left ventricular dyssynchrony and may worsen left ventricular systolic dysfunction and HF. Whether conventional pacing is also associated with worse outcomes in HFpEF is unknown.

Methods: Patient data were pooled from the CHARM-Preserved (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity), I-PRESERVE (Irbesartan in Heart Failure with Preserved Ejection Fraction), and TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial) studies and were examined for the association between having a pacemaker and the risk of the primary composite of cardiovascular death or HF hospitalization, the individual components of the composite, the 2 main modes of cardiovascular death (i.e., sudden death and pump failure death), and all-cause death in unadjusted and adjusted analyses.

Results: Of the 8,466 patients included, 682 patients (8%) had a pacemaker. Pacemaker patients were older and more often men and had lower body mass indexes, estimated glomerular filtration rates, and blood pressures but higher concentrations of N-terminal pro-B-type natriuretic peptide than those without a pacemaker. The rate of the primary composite outcome in pacemaker patients was almost twice that in patients without a pacemaker (13.6 vs. 7.6 per 100 patient-years of follow up, respectively), with a similar finding for HF hospitalizations (10.8 vs. 5.1 per 100 patient-years, respectively). This risk rate persisted after adjusting for other prognostic variables (hazard ratio [HR] for the composite outcome: 1.17; 95% confidence interval [CI]: 1.02 to 1.33; p = 0.026), driven mainly by HF hospitalization (HR: 1.37; 95% CI: 1.17 to 1.60; p < 0.001). The risk of death was not significantly higher in pacemaker patients in the adjusted analyses.

Conclusions: These findings raise the possibility that right ventricular pacing-induced left ventricular dyssynchrony may be detrimental in HFpEF patients.
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http://dx.doi.org/10.1016/j.jchf.2018.12.006DOI Listing
May 2019

Predicting Future Health Transitions Among Newly Admitted Nursing Home Residents With Heart Failure.

J Am Med Dir Assoc 2019 04 17;20(4):438-443. Epub 2018 Dec 17.

Department of Medicine, Western University, London, Ontario, Canada.

Objectives: To understand how a heart failure diagnosis and admission health instability predict health transitions and outcomes among newly admitted nursing home residents.

Design: Retrospective cohort study of linked administrative data, including the Continuing Care Report System MDS 2.0 for nursing homes, the Discharge Abstract Database for hospitalized patients, and National Ambulatory Care Reporting System to track emergency department visits.

Setting And Participants: Older adults, aged 65 years and above, admitted to nursing homes in Ontario, Alberta, and British Columbia, Canada, from 2010 to 2016.

Measures: Mortality and hospitalization were plotted over 1 year. Multistate Markov models were used to estimate adjusted odds ratios (ORs) for transitions to different states of health in stability, hospitalization, and death, stratified by heart failure diagnosis and by interRAI Changes in Health and End-stage disease Signs and Symptoms (CHESS) score, at 90 days following admission to a nursing home.

Results: The final sample included 143,067 residents. Adverse events were most common in the first 90 days. A diagnosis of heart failure predicted worsening health instability, hospitalizations, and mortality. The effect of heart failure on hospitalizations and death was strongest for low baseline health instability (CHESS = 0; OR 1.63, 95% confidence interval (CI) 1.58-1.68, and OR 1.71, 95% CI 1.57-1.86, respectively), versus moderate instability (CHESS = 1-2; OR 1.36, 95% CI 1.32-1.39, and OR 1.48, 95% CI 1.41-1.55), versus high instability (CHESS = 3; OR 1.12, 95% CI 1.03-1.23, and OR 1.21, 95% CI 1.11-1.32). The magnitude of the impact of a heart failure diagnosis was greatest for lower baseline health instability. Residents with the highest degree of health instability were also most likely to die in hospital.

Conclusions And Implications: A diagnosis of heart failure and health instability provide complementary information to predict transfers, deaths, and adverse outcomes. Clearly identifying these at-risk patients may be useful in targeting interventions in nursing homes.
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http://dx.doi.org/10.1016/j.jamda.2018.10.031DOI Listing
April 2019

Impact of exercise-based cardiac rehabilitation in patients with heart failure (ExTraMATCH II) on mortality and hospitalisation: an individual patient data meta-analysis of randomised trials.

Eur J Heart Fail 2018 12 26;20(12):1735-1743. Epub 2018 Sep 26.

National Knowledge Centre for Rehabilitation and Palliative Care, University Hospital Odense and University of Southern Denmark, Nyborg, Denmark.

Aims: To undertake an individual patient data (IPD) meta-analysis to assess the impact of exercise-based cardiac rehabilitation (ExCR) in patients with heart failure (HF) on mortality and hospitalisation, and differential effects of ExCR according to patient characteristics: age, sex, ethnicity, New York Heart Association functional class, ischaemic aetiology, ejection fraction, and exercise capacity.

Methods And Results: Randomised trials of exercise training for at least 3 weeks compared with no exercise control with 6-month follow-up or longer, providing IPD time to event on mortality or hospitalisation (all-cause or HF-specific). IPD were combined into a single dataset. We used Cox proportional hazards models to investigate the effect of ExCR and the interactions between ExCR and participant characteristics. We used both two-stage random effects and one-stage fixed effect models. IPD were obtained from 18 trials including 3912 patients with HF with reduced ejection fraction. Compared to control, there was no statistically significant difference in pooled time to event estimates in favour of ExCR although confidence intervals (CIs) were wide [all-cause mortality: hazard ratio (HR) 0.83, 95% CI 0.67-1.04; HF-specific mortality: HR 0.84, 95% CI 0.49-1.46; all-cause hospitalisation: HR 0.90, 95% CI 0.76-1.06; and HF-specific hospitalisation: HR 0.98, 95% CI 0.72-1.35]. No strong evidence was found of differential intervention effects across patient characteristics.

Conclusion: Exercise-based cardiac rehabilitation did not have a significant effect on the risk of mortality and hospitalisation in HF with reduced ejection fraction. However, uncertainty around effect estimates precludes drawing definitive conclusions.
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http://dx.doi.org/10.1002/ejhf.1311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7262555PMC
December 2018

Heart Failure Management in Nursing Homes: A Scoping Literature Review.

Can J Cardiol 2018 07 11;34(7):871-880. Epub 2018 Apr 11.

Department of Medicine, Western University, London, Ontario, Canada.

Heart failure (HF) affects 20% of nursing home (NH) residents, causing high morbidity and mortality. The optimal approach to HF management in NHs remains elusive. We conducted a scoping review of published guidelines and HF management interventions in NHs. A search for English publications since 1990 was conducted using PubMed, EMBASE, CINAHL, and Scopus, for scientific statements, guidelines, recommendations, or intervention studies that addressed at least 1 principle of HF management. Of 2545 records retrieved, 19 articles were retained after screening, and 2 additional articles identified through reference list manual searches. Six articles represented 5 guidelines and 15 described interventions. All guidelines endorsed the applicability of general HF guidelines to NH residents, tailored to comorbidities, frailty, and advance care preferences. Four addressed quality assurance but not feasibility and sustainability. Methodological quality of the interventions was poor, although results suggest that guideline-based HF management in NHs can improve nursing staff knowledge and job satisfaction, prescribing, and reduce acute care utilization. Clinically-based education for staff, and access to specialist mentorship are important. NH physician involvement was limited, and resident/family education potentially ineffective. Concerns about feasibility, sustainability, and quality assurance were identified in most interventions, and advance care planning was rarely addressed. HF guidelines for NH support the applicability of general HF guidelines to the care of NH residents, and published interventions suggest that guideline-based HF management in NHs is effective. Future work should support greater physician and resident engagement, advance care planning, and provide robust guidelines on developing feasible and sustainable interventions.
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http://dx.doi.org/10.1016/j.cjca.2018.04.006DOI Listing
July 2018

The Spoke-Hub-and-Node Model of Integrated Heart Failure Care.

Can J Cardiol 2018 07 4;34(7):863-870. Epub 2018 May 4.

Western University, London, Ontario, Canada. Electronic address:

Heart failure (HF) is a significant public health concern. Specialized HF clinics provide the optimal environment to address the complex needs of these patients and improve outcomes. The current and growing population of patients with HF outstrips the ability of these clinics to deliver care. Integrated care is defined as health services that are managed and delivered so that people receive a seamless continuum of health promotion, disease prevention, diagnosis, treatment, disease management, rehabilitation, and palliative care services. This approach requires coordination across different levels and sites of care within and beyond the health sector, according to changing patient needs throughout their lives. The spoke-hub-and-node (SHN) model represents an organization of care that works collaboratively with the primary care sector and is highly integrated with community-based multidisciplinary teams of health care professionals and specialty care. The purpose of this article is to analyze the requirements for successful implementation of SHN models. We consider the respective roles of HF clinics, HF nurse specialists, pharmacists, palliative care teams, telemonitoring, and solo practitioners. We also discuss levels of care delivery and the importance of patient stratification and patient flow. The SHN approach has the potential to build on and improve the chronic care model (CCM) to deliver centralized services to preserve high-quality patient-centred care at affordable costs.
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http://dx.doi.org/10.1016/j.cjca.2018.04.029DOI Listing
July 2018

"NEW" Prehabilitation: A 3-Way Approach to Improve Postoperative Survival and Health-Related Quality of Life in Cardiac Surgery Patients.

Can J Cardiol 2018 07;34(7):839-849

Schulich School of Medicine, Western University, London, Ontario, Canada.

With advances in health care practices and delivery, the overall life expectancy of the Western population has increased. For those practitioners involved in the care of the patient with advanced cardiac disease, there has been a resultant higher prevalence of increasingly frail and older patients undergoing complex cardiac procedures. The higher rates of comorbid-associated higher vulnerability, with associated deconditioning, predisposes older, frail patients to poorer postoperative outcomes and a complicated recovery process after cardiac surgery. In addition, such patients experience inferior quality of life as a result of reduced ability to independently perform activities of daily living. During the preoperative waiting period, the cardiac symptoms and anxiety induces inactivity that in turn compounds the physical and mental deconditioning. To improve functional capacity and enhance postoperative recovery, prehabilitation, a component of the enhanced recovery after surgery model, might be of particular importance. In some studies, the preoperative improvement of the baseline physical, nutritional, and mental status has been reported to improve postoperative outcomes and enhance recovery after cardiac surgery. To address these domains, a 3-way approach to prehabilitation that is targeted toward improving nutritional status (N), exercise capacity (E) and worry reduction (W) (nutrition, exercise, and worry; "NEW" approach) might facilitate the perioperative management by ameliorating the postoperative outcomes and alleviating the surgical stress-related health deconditioning. In this review, the NEW approach and its potential benefits on postoperative outcomes as well as an implementation model (Promoting Action on Research Implementation in Health Services [PARiHS] framework) to aid institutional level implementation is described.
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http://dx.doi.org/10.1016/j.cjca.2018.03.020DOI Listing
July 2018

Management of Non-ST-Elevation Myocardial Infarction in Elderly Patients: Time to Consider Frailty and Quality of Life.

Can J Cardiol 2018 03 2;34(3):241-243. Epub 2018 Feb 2.

Department of Medicine, Division of Cardiology, Western University and St. Joseph's Health Care, London, Ontario, Canada. Electronic address:

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http://dx.doi.org/10.1016/j.cjca.2018.01.089DOI Listing
March 2018

Individualizing the care of older heart failure patients.

Curr Opin Cardiol 2018 03;33(2):208-216

Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

Purpose Of Review: The heart failure epidemic is driven mainly by population aging and the improving survival of patients with cardiovascular risk factors. Aging heart failure patients are affected by multiple concurrent comorbidities and geriatric syndromes, the most important of which are frailty and cognitive impairment. The purpose of this review is to provide clinicians with practical advice on how to individualize the care of older heart failure patients.

Recent Findings: Frailty and cognitive impairment are common in older heart failure patients. Frailty is increasingly recognized as a key risk factor for functional decline, health service utilization and mortality in aging heart failure patients. Similarly, cognitive impairment impairs patients' ability for self-care and leads to adverse outcomes. Simple and efficient instruments exist to screen for these conditions. Heart failure patients who are frail or cognitively impaired are best looked after in a disease management setting that is deployed in a more integrated healthcare system with access to specialized geriatric consultants. Optimal care planning requires knowledge of these conditions as well as patient and caregiver engagement.

Summary: Frailty and cognitive impairment are central features of the heart failure syndrome in aging patients and should be routinely considered in assessment and care planning.
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http://dx.doi.org/10.1097/HCO.0000000000000489DOI Listing
March 2018

2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure.

Can J Cardiol 2017 11 6;33(11):1342-1433. Epub 2017 Sep 6.

Memorial University, St John's, Newfoundland, Canada.

Since the inception of the Canadian Cardiovascular Society heart failure (HF) guidelines in 2006, much has changed in the care for patients with HF. Over the past decade, the HF Guidelines Committee has published regular updates. However, because of the major changes that have occurred, the Guidelines Committee believes that a comprehensive reassessment of the HF management recommendations is presently needed, with a view to producing a full and complete set of updated guidelines. The primary and secondary Canadian Cardiovascular Society HF panel members as well as external experts have reviewed clinically relevant literature to provide guidance for the practicing clinician. The 2017 HF guidelines provide updated guidance on the diagnosis and management (self-care, pharmacologic, nonpharmacologic, device, and referral) that should aid in day-to-day decisions for caring for patients with HF. Among specific issues covered are risk scores, the differences in management for HF with preserved vs reduced ejection fraction, exercise and rehabilitation, implantable devices, revascularization, right ventricular dysfunction, anemia, and iron deficiency, cardiorenal syndrome, sleep apnea, cardiomyopathies, HF in pregnancy, cardio-oncology, and myocarditis. We devoted attention to strategies and treatments to prevent HF, to the organization of HF care, comorbidity management, as well as practical issues around the timing of referral and follow-up care. Recognition and treatment of advanced HF is another important aspect of this update, including how to select advanced therapies as well as end of life considerations. Finally, we acknowledge the remaining gaps in evidence that need to be filled by future research.
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http://dx.doi.org/10.1016/j.cjca.2017.08.022DOI Listing
November 2017

Implementation of an interprofessional communication and collaboration intervention to improve care capacity for heart failure management in long-term care.

J Interprof Care 2017 Sep 6;31(5):583-592. Epub 2017 Sep 6.

h School of Public Health and Health Systems , University of Waterloo , Waterloo , Ontario , Canada.

Heart failure affects up to 20% of nursing home residents and is associated with high morbidity, mortality, and transfers to acute care. A major barrier to heart failure management in nursing home settings is limited interprofessional communication. Guideline-based heart failure management programs in nursing homes can reduce hospitalisation rates, though sustainability is limited when interprofessional communication is not addressed. A pilot intervention, 'Enhancing Knowledge and Interprofessional Care for Heart Failure', was implemented on two units in two conveniently selected nursing homes to optimise interprofessional care processes amongst the care team. A core heart team was established, and participants received tailored education focused on heart failure management principles and communication processes, as well as weekly mentoring. Our previous work provided evidence for this intervention's acceptability and implementation fidelity. This paper focuses on the preliminary impact of the intervention on staff heart failure knowledge, communication, and interprofessional collaboration. To determine the initial impact of the intervention on selected staff outcomes, we employed a qualitative design, using a social constructivist interpretive framework. Findings indicated a perceived increase in team engagement, interprofessional collaboration, communication, knowledge about heart failure, and improved clinical outcomes. Individual interviews with staff revealed innovative ways to enhance communication, supporting one another with knowledge and engagement in collaborative practices with residents and families. Engaging teams, through the establishment of core heart teams, was successful to develop interprofessional communication processes for heart failure management. Further steps to be undertaken include assessing the sustainability and effectiveness of this approach with a larger sample.
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http://dx.doi.org/10.1080/13561820.2017.1340875DOI Listing
September 2017

Enhancing Knowledge and InterProfessional care for Heart Failure (EKWIP-HF) in long-term care: a pilot study.

Pilot Feasibility Stud 2018 6;4. Epub 2017 Jul 6.

Western University, London, Ontario Canada.

Background: Heart failure (HF) affects 20% of long-term care (LTC) residents and is associated with significant morbidity, acute care visits, and mortality. Barriers to HF management are staff knowledge gaps and ineffective interprofessional (IP) communication. This pilot study assessed the acceptability, feasibility, and impact of an intervention to (1) improve HF knowledge; (2) improve IP communication; and (3) integrate improved knowledge and communication processes into work routines.

Methods: The intervention provides multimodal IP education about HF in LTC, including specialist-supported bedside teaching. It was piloted on single units in two facilities. A mixed-methods repeated-measures approach was used to collect qualitative and quantitative process and outcome data at baseline and 6 months post-intervention.

Results: Results were similar at both sites. Participants developed optimized IP communication to promote HF care. Results indicate a perceived increase in staff confidence and self-efficacy, strengthened assessment and clinical proficiency skills, and more effective IP collaboration. Staff deemed the intervention useful and feasible.

Conclusions: This pilot study suggests that a novel intervention in which HF-specific knowledge is applied by LTC staff to improve IP collaboration in their own work place is acceptable and feasible and has a favourable preliminary impact on staff knowledge and IP communication.
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http://dx.doi.org/10.1186/s40814-017-0153-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501130PMC
July 2017

Global mortality variations in patients with heart failure: results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study.

Lancet Glob Health 2017 07 3;5(7):e665-e672. Epub 2017 May 3.

Population Health Research Institute, McMaster University, Hamilton, Canada.

Background: Most data on mortality and prognostic factors in patients with heart failure come from North America and Europe, with little information from other regions. Here, in the International Congestive Heart Failure (INTER-CHF) study, we aimed to measure mortality at 1 year in patients with heart failure in Africa, China, India, the Middle East, southeast Asia and South America; we also explored demographic, clinical, and socioeconomic variables associated with mortality.

Methods: We enrolled consecutive patients with heart failure (3695 [66%] clinic outpatients, 2105 [34%] hospital in patients) from 108 centres in six geographical regions. We recorded baseline demographic and clinical characteristics and followed up patients at 6 months and 1 year from enrolment to record symptoms, medications, and outcomes. Time to death was studied with Cox proportional hazards models adjusted for demographic and clinical variables, medications, socioeconomic variables, and region. We used the explained risk statistic to calculate the relative contribution of each level of adjustment to the risk of death.

Findings: We enrolled 5823 patients within 1 year (with 98% follow-up). Overall mortality was 16·5%: highest in Africa (34%) and India (23%), intermediate in southeast Asia (15%), and lowest in China (7%), South America (9%), and the Middle East (9%). Regional differences persisted after multivariable adjustment. Independent predictors of mortality included cardiac variables (New York Heart Association Functional Class III or IV, previous admission for heart failure, and valve disease) and non-cardiac variables (body-mass index, chronic kidney disease, and chronic obstructive pulmonary disease). 46% of mortality risk was explained by multivariable modelling with these variables; however, the remainder was unexplained.

Interpretation: Marked regional differences in mortality in patients with heart failure persisted after multivariable adjustment for cardiac and non-cardiac factors. Therefore, variations in mortality between regions could be the result of health-care infrastructure, quality and access, or environmental and genetic factors. Further studies in large, global cohorts are needed.

Funding: The study was supported by Novartis.
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http://dx.doi.org/10.1016/S2214-109X(17)30196-1DOI Listing
July 2017

Risk of stroke in chronic heart failure patients with preserved ejection fraction, but without atrial fibrillation: analysis of the CHARM-Preserved and I-Preserve trials.

Eur Heart J 2017 Mar;38(10):742-750

BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow G12 8TA, UK.

Aims: The incidence and predictors of stroke in patients with heart failure and preserved ejection fraction (HF-PEF), but without atrial fibrillation (AF), are unknown. We described the incidence of stroke in HF-PEF patients with and without AF and predictors of stroke in those without AF.

Methods And Results: We pooled data from the CHARM-Preserved and I-Preserve trials. Using Cox regression, we derived a model for stroke in patients without AF in this cohort and compared its performance with a published model in heart failure patients with reduced ejection fraction (HF-REF)-predictive variables: age, body mass index, New York Heart Association class, history of stroke, and insulin-treated diabetes. The two stroke models were compared and Kaplan-Meier curves for stroke estimated. The risk model was validated in a third HF-PEF trial. Of the 6701 patients, 4676 did not have AF. Stroke occurred in 124 (6.1%) with AF and in 171 (3.7%) without AF (rates 1.80 and 1.00 per 100 patient-years, respectively). There was no difference in performance of the stroke model derived in the HF-PEF cohort and the published HF-REF model (c-index 0.71, 95% confidence interval 0.57-0.84 vs. 0.73, 0.59-0.85, respectively) as the predictive variables overlapped. The model performed well in the validation cohort (0.86, 0.62-0.99). The rate of stroke in patients in the upper third of risk approximated to that in patients with AF (1.60 and 1.80 per 100 patient-years, respectively).

Conclusions: A small number of clinical variables identify a subset of patients with HF-PEF, but without AF, at elevated risk of stroke.
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http://dx.doi.org/10.1093/eurheartj/ehw509DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5460584PMC
March 2017

Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction).

Circulation 2017 Feb 4;135(8):724-735. Epub 2017 Jan 4.

From BHF Cardiovascular Research Centre, University of Glasgow, Scotland, UK (S.L.K., U.M.M., P.S.J., M.C.P., J.J.V.M.); Department of Cardiology, Rigshospitalet University Hospital, Copenhagen, Denmark (S.L.K., U.M.M., L.K.); Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK (D.P.); Mayo Clinic, Rochester, MN (S.W.); Western University, London, ON, Canada (R.S.M.); Ralph H. Johnsons Veterans Affairs Medical Center and Medical University of South Carolina, Charleston (M.R.Z.); Division of Cardiology, University of Minnesota, Minneapolis (I.S.A.); Université Paris 6 and Hospital Pitié-Salpétrière, Paris, France (M.K.); University of Maryland Medical Center, Baltimore (J.S.G.); and Georgetown University and Washington DC Veterans Affairs Medical Center (P.E.C.).

Background: In patients with heart failure and preserved ejection fraction, little is known about the characteristics of, and outcomes in, those with and without diabetes mellitus.

Methods: We examined clinical and echocardiographic characteristics and outcomes in the I-Preserve trial (Irbesartan in Heart Failure With Preserved Ejection Fraction) according to history of diabetes mellitus. Cox regression models were used to estimate hazard ratios for cardiovascular outcomes adjusted for known predictors, including age, sex, natriuretic peptides, and comorbidity. Echocardiographic data were available in 745 patients and were additionally adjusted for in supplementary analyses.

Results: Overall, 1134 of 4128 patients (27%) had diabetes mellitus. Compared with those without diabetes mellitus, they were more likely to have a history of myocardial infarction (28% versus 22%), higher body mass index (31 versus 29 kg/m), worse Minnesota Living With Heart Failure score (48 versus 40), higher median N-terminal pro-B-type natriuretic peptide concentration (403 versus 320 pg/mL; all <0.01), more signs of congestion, but no significant difference in left ventricular ejection fraction. Patients with diabetes mellitus had a greater left ventricular mass and left atrial area than patients without diabetes mellitus. Doppler E-wave velocity (86 versus 76 cm/s; <0.0001) and the E/e' ratio (11.7 versus 10.4; =0.010) were higher in patients with diabetes mellitus. Over a median follow-up of 4.1 years, cardiovascular death or heart failure hospitalization occurred in 34% of patients with diabetes mellitus versus 22% of those without diabetes mellitus (adjusted hazard ratio, 1.75; 95% confidence interval, 1.49-2.05), and 28% versus 19% of patients with and without diabetes mellitus died (adjusted hazard ratio, 1.59; confidence interval, 1.33-1.91).

Conclusions: In heart failure with preserved ejection fraction, patients with diabetes mellitus have more signs of congestion, worse quality of life, higher N-terminal pro-B-type natriuretic peptide levels, and a poorer prognosis. They also display greater structural and functional echocardiographic abnormalities. Further investigation is needed to determine the mediators of the adverse impact of diabetes mellitus on outcomes in heart failure with preserved ejection fraction and whether they are modifiable.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00095238.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.116.024593DOI Listing
February 2017