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BACKGROUND: Healthcare workers (HCWs) including community health extension workers (CHEWs) in the Federal Capital Territory, Nigeria participated in a hypertension training series following the Extension for Community Healthcare Outcomes (ECHO) model which leverages technology and a practical peer-to-peer learning framework to virtually train healthcare practitioners. We sought to evaluate the patient-level effects of the hypertension ECHO series. METHODS: HCWs from 12 of 33 eligible primary healthcare centers (PHCs) in the Hypertension Treatment in Nigeria Program (NCT04158154) were selected to participate in a seven-part hypertension ECHO series from August 2022 to April 2023. Concurrent Hypertension Treatment in Nigeria Program patient data were used to evaluate changes in hypertension treatment and control rates, and adherence to Nigeria's hypertension treatment protocol. Outcomes were compared between the 12 PHCs in the ECHO program and the 21 which were not. RESULTS: Between July 2022 and June 2023, 16,691 PHC visits were documented among 4340 individuals (ECHO: n = 1428 [33%], non-ECHO: n = 2912 [67%]). Patients were on average (SD) 51.5 (12.0) years old, and one-third were male (n = 1372, 32%) with no differences between cohorts in either characteristic (p ≥ 0.05 for both). Blood pressures at enrollment were higher in the ECHO cohort compared to the non-ECHO cohort (systolic p < 0.0001 and diastolic p = 0.0001), and patients were less likely to be treated with multiple medications (p < 0.0001). Treatment rates were similar at baseline (ECHO: 94.0% and Non-ECHO: 94.7%) and increased at a higher rate (interaction p = 0.045) in the ECHO cohort over time. After adjustment for baseline and within site variation, the difference was attenuated (interaction p = 0.37). Over time, control rates increased and medication protocol adherence decreased, with no differences between cohorts. Staffing levels, adult patient visits, and rates of hypertension screening and empanelment were similar between ECHO and non-ECHO cohorts (p ≥ 0.05 for all). CONCLUSIONS: The ECHO series was associated with moderately increased hypertension treatment rates and did not adversely affect staffing or clinical capacity among PHCs in the Federal Capital Territory, Nigeria. These results may be used to inform strategies to support scaling hypertension education among frontline HCWs throughout Nigeria, and use of the ECHO model for CHEWs. TRIAL REGISTRATION: The Hypertension Treatment in Nigeria Program was prospectively registered on November 8, 2019 at www. CLINICALTRIALS: gov (NCT04158154; https://clinicaltrials.gov/ct2/show/NCT04158154 ).
Subject(s)
Community Health Workers , Hypertension , Primary Health Care , Humans , Hypertension/drug therapy , Hypertension/epidemiology , Hypertension/therapy , Nigeria/epidemiology , Male , Community Health Workers/education , Female , Middle Aged , Adult , Antihypertensive Agents/therapeutic useABSTRACT
INTRODUCTION: Noncommunicable diseases (NCDs) are associated with high and rising burden of morbidity and mortality in sub-Saharan Africa, including Nigeria. Diabetes mellitus (DM) is among the leading causes of NCD-related deaths worldwide and is a foremost public health problem in Nigeria. As part of National policy, Nigeria has committed to implement the World Health Organization (WHO) Package of Essential Non-communicable Disease interventions for primary care. Implementing the intervention requires the availability of essential elements, including guidelines, trained staff, health management information systems (HMIS), equipment, and medications, in primary healthcare centers (PHCs). This study assessed the availability of the DM component of the WHO package, and the readiness of the health workers in these PHCs to implement a DM screening, evaluation, and management program to inform future adoption and implementation. METHODS: This cross-sectional formative assessment adapted the WHO Service Availability and Readiness Assessment (SARA) tool to survey 30 PHCs selected by multistage sampling for readiness to deliver DM diagnosis and care in Abuja, Nigeria, between August and October 2021. The SARA tool was adapted to focus on DM services and the availability and readiness indicator scores were calculated based on the proportion of PHCs with available DM care services, minimum staff requirement, diagnostic tests, equipment, medications, and national guidelines/protocols for DM care within the defined SARA domain. RESULTS: All 30 PHCs reported the availability of at least two full-time staff (median [interquartile range] = 5 [4-9]), which were mostly community health extension workers (median [interquartile range]) = 3 [1-4]. At least one staff member was recently trained in DM care in 11 PHCs (36%). The study also reported high availability of paper-based HMIS (100%), and DM screening services using a glucometer (87%), but low availability of DM job aids (27%), treatment (23%), and national guidelines/protocols (0%). CONCLUSION: This formative assessment of PHCs' readiness to implement a DM screening, evaluation, and management program in Abuja demonstrated readiness to integrate DM care into PHCs regarding equipment, paper-based HMIS, and nonphysician health workers' availability. However, strategies are needed to promote DM health workforce training, provide DM management guidelines, and supply essential DM medications.
Subject(s)
Diabetes Mellitus , Primary Health Care , Humans , Nigeria/epidemiology , Cross-Sectional Studies , Diabetes Mellitus/therapy , Diabetes Mellitus/diagnosis , Diabetes Mellitus/epidemiologyABSTRACT
BACKGROUND: Caregivers of patients with advanced heart failure may experience burden in providing care, but whether changes in patient health status are associated with caregiver burden is unknown. METHODS: This observational study included older patients (60-80 years old) receiving advanced surgical heart failure therapies and their caregivers at 13 US sites. Patient health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (range, 0-100; higher scores are better). Caregiver burden was assessed using the Oberst Caregiving Burden Scale, which measures time on task (OCBS-time) and task difficulty (OCBS-difficulty; range, 1-5; lower scores are better). Measurements occurred before surgery and 12 months after in 3 advanced heart failure cohorts: patients receiving long-term left ventricular assist device support; heart transplantation with pretransplant left ventricular assist device support; and heart transplantation without pretransplant left ventricular assist device support. Multivariable linear regression was used to identify predictors of change in OCBS-time and OCBS-difficulty at 12 months. RESULTS: Of 162 caregivers, the mean age was 61.0±9.4 years, 139 (86%) were female, and 140 (86%) were the patient's spouse. At 12 months, 99 (61.1%) caregivers experienced improved OCBS-time, and 61 (37.7%) experienced improved OCBS-difficulty (versus no change or worse OCBS). A 10-point higher baseline 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (ß=-0.09 [95% CI, -0.14 to -0.03]; P<0.001) and OCBS-difficulty (ß=-0.08 [95% CI, -0.12 to -0.05]; P<0.001). Each 10-point improvement in the 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (ß=-0.07 [95% CI, -0.12 to -0.03]; P=0.002) and OCBS-difficulty (ß=-0.09 [95% CI, -0.12 to -0.06]; P<0.001). CONCLUSIONS: Among survivors at 12 months, baseline and change in patient health status were associated with subsequent caregiver time on task and task difficulty in dyads receiving advanced heart failure surgical therapies, highlighting the potential for serial 12-item Kansas City Cardiomyopathy Questionnaire assessments to identify caregivers at risk of increased burden. REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT02568930.
Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Patient Reported Outcome Measures , Humans , Heart Failure/therapy , Heart Failure/psychology , Female , Male , Aged , Middle Aged , Aged, 80 and over , Caregivers/psychology , Caregiver Burden/psychology , Health Status , Quality of Life , Surveys and Questionnaires , United States , Time Factors , Cost of IllnessABSTRACT
BACKGROUND: Tricuspid valve transcatheter edge-to-edge repair (T-TEER) is the most widely used transcatheter therapy to treat patients with tricuspid regurgitation (TR). OBJECTIVES: The aim of this study was to develop a simple anatomical score to predict procedural outcomes of T-TEER. METHODS: All patients (n = 168) who underwent T-TEER between January 2017 and November 2022 at 2 centers were included in the derivation cohort. Additionally, 126 patients from 2 separate institutions served as a validation cohort. T-TEER was performed using 2 commercially available technologies. Core laboratory assessment of procedural transesophageal echocardiograms was used to determine septolateral and anteroposterior coaptation gap, leaflet morphology, septal leaflet length and retraction, chordal structure density, tethering height, en face TR jet morphology and TR jet location, image quality, and the presence of intracardiac leads. A scoring system was derived using univariable and multivariable logistic regression. Endpoints assessed were immediate postprocedural TR reduction ≥2 grades and TR grade moderate or less. RESULTS: The median age was 82 years (Q1-Q3: 78-84 years); 48% of patients were women; and patients presented with severe (55%), massive (36%), and torrential (8%) TR. Five variables (septolateral coaptation gap, chordal structure density, en face TR jet morphology, TR jet location, and image quality) were identified as best predicting procedural outcome and were incorporated in the GLIDE (Gap, Location, Image quality, density, en-face TR morphology) score (range 0-5). TR reduction ≥2 grades and TR grade moderate or less were observed in >90% of patients with GLIDE scores of 0 and 1 and in only 5.6% and 16.7% of those with GLIDE scores ≥4. The GLIDE score was then externally validated in a separate cohort (area under the curve: 0.77; 95% CI: 0.69-0.86). TR reduction significantly correlated with functional improvement assessed by NYHA functional class and 6-minute walk distance at 3 months. CONCLUSIONS: The GLIDE score is a simple, 5-component score that is readily obtained during patient imaging and can predict successful T-TEER.
Subject(s)
Cardiac Catheterization , Echocardiography, Transesophageal , Predictive Value of Tests , Recovery of Function , Tricuspid Valve Insufficiency , Tricuspid Valve , Humans , Female , Male , Aged , Tricuspid Valve Insufficiency/diagnostic imaging , Tricuspid Valve Insufficiency/physiopathology , Tricuspid Valve Insufficiency/surgery , Tricuspid Valve/diagnostic imaging , Tricuspid Valve/physiopathology , Tricuspid Valve/surgery , Treatment Outcome , Aged, 80 and over , Reproducibility of Results , Retrospective Studies , Risk Factors , Decision Support Techniques , Risk Assessment , Time FactorsABSTRACT
Background: The desire of patients to avoid anticoagulation, together with the potential of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR), have resulted in the increasing use of bioprosthetic valves for aortic valve replacement (AVR). While patient-prosthesis mismatch (PPM) is known to be an adverse risk after AVR, few studies have addressed the effect of PPM on valve durability. This study evaluates the role of valve size and hemodynamics on long term durability after AVR with a Magna bioprosthesis. Methods: We performed a retrospective, single-center evaluation of patients who underwent a surgical AVR procedure between June 2004 through December 2022 using the Magna bioprosthesis. Perioperative information and long-term follow-up data were sourced from the institution's Society for Thoracic Surgeons Adult Cardiac Surgery Registry and outcomes database. Cumulative incidence of freedom from reintervention were estimated accounting for competing events. Group comparisons used Gray's test. Results: Among 2,100 patients, the mean patient age was 69 years (range, 22-95 years), of whom 98% had native aortic valve disease, 32.5% had concomitant coronary bypass grafting, and 19% had mitral valve surgery. Median follow-up was 5.8 (1.9-9.4) years, during which 116 reinterventions were performed, including 74 explants and 42 VIV procedures. Nine hundred and twenty-eight patients died prior to reintervention. Incidence of all cause reintervention was 1.2%, 4.5%, and 11.7% at 5, 10, and 15 years, respectively. Smaller valve size was associated with worse survival (P<0.001), but not with reintervention. Higher mean gradient at implant was associated with increased late reintervention [sub-distribution hazard ratio: 1.016; 95% confidence interval (CI): 1.005 to 1.028; P=0.0047, n=1,661]. Conclusions: While reintervention rates are low for the Magna prosthesis at 15 years, the analysis is confounded by the competing risk of death. PPM, as reflected physiologically by elevated post-operative valve gradients, portends an increased risk of intervention. Further study is necessary to elucidate the mechanism of early stenosis in patients who progress to reintervention.
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It is unknown whether racial disparities in access to heart transplantation (HT) are amplified when coupled with substance use. We examined patients evaluated for HT over 8 years at an urban transplant center. We evaluated substance use and race/ethnicity as independent and interactive predictors of HT and left ventricular assist device (LVAD) implantation. Of 1,148 patients evaluated for HT, substance use was cited as an ineligibility factor in 151 (13%) patients, 16 (11%) of whom ultimately received HT. Significantly more non-Hispanic Black (NHB) patients were deemed ineligible due to substance use (n = 59, 19%) compared to other races/ethnicities (non-Hispanic white: n = 68, 12%; other race/ethnicity: n = 24, p = 0.002). No racial differences were observed in the likelihood of HT among patients initially excluded for substances, but more NHB patients ultimately received LVAD than the other racial groups. This study encourages greater awareness of the role of substance use and race in the HT evaluation.
Subject(s)
Heart Transplantation , Heart-Assist Devices , Substance-Related Disorders , Humans , Heart Transplantation/statistics & numerical data , Male , Female , Middle Aged , Substance-Related Disorders/epidemiology , Substance-Related Disorders/ethnology , Adult , Retrospective Studies , White People/statistics & numerical data , Black or African American/statistics & numerical data , Racial Groups/statistics & numerical data , Aged , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , Heart Failure/surgery , Heart Failure/ethnologyABSTRACT
New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312.
Subject(s)
Amlodipine , Antihypertensive Agents , Benzimidazoles , Biphenyl Compounds , Bisoprolol , Blood Pressure , Hypertension , Tetrazoles , Humans , Female , Male , Hypertension/drug therapy , Middle Aged , Antihypertensive Agents/therapeutic use , Antihypertensive Agents/adverse effects , Antihypertensive Agents/administration & dosage , Double-Blind Method , Benzimidazoles/therapeutic use , Benzimidazoles/adverse effects , Benzimidazoles/administration & dosage , Amlodipine/administration & dosage , Amlodipine/adverse effects , Amlodipine/therapeutic use , Tetrazoles/therapeutic use , Tetrazoles/adverse effects , Tetrazoles/administration & dosage , Blood Pressure/drug effects , Aged , Treatment Outcome , Bisoprolol/therapeutic use , Bisoprolol/administration & dosage , Indapamide/therapeutic use , Indapamide/administration & dosage , Indapamide/adverse effects , Adult , Drug Therapy, CombinationABSTRACT
Introduction: Noncommunicable diseases (NCDs) are associated with a high and rising burden of morbidity and mortality in sub-Saharan Africa, including Nigeria. Diabetes mellitus (DM) is among the leading causes of NCD-related deaths worldwide and is a foremost public health problem in Nigeria. As part of the National Multi-Sectoral Action Plan for the Prevention and Control of NCDs, Nigeria has committed to implementing the World Health Organization (WHO) Package of Essential NCD control interventions. Implementing the intervention requires the availability of essential elements, including guidelines, trained staff, health management information systems, equipment, and medications, in primary healthcare centers (PHCs). This study assessed the availability of the WHO package components and the readiness of PHCs to implement a DM screening, evaluation, and management program. Methods: This cross-sectional formative assessment adapted the WHO Service Availability and Readiness Assessment (SARA) tool to survey 30 PHCs selected by multistage sampling for readiness to deliver DM diagnosis and care in Abuja, Nigeria, between August 2021 and October 2021. The service availability and readiness indicator scores were calculated based on the proportion of PHCs with available DM care services, minimum staff requirement, diagnostic tests, equipment, medications, and national guidelines/protocols for DM care within the defined SARA domain. Results: All 30 PHCs reported the availability of at least two full-time staff (median [interquartile range] staff = 5 [4-9]), which were mostly community health extension workers (median [interquartile range]) = 3 [1-4]. At least one staff member was recently trained in DM care in only 11 (36%) of the PHCs. The study also reported high availability (100%) of paper-based health management information systems (HMIS) and DM screening services using a glucometer (87%), but low availability of DM treatment (23%), printed job aids (27%), and national guidelines/protocols (0%). Conclusion: This systematic assessment of PHCs' readiness to implement a DM screening, evaluation, and management program in Abuja demonstrated readiness to integrate DM care into PHCs in terms of equipment, paper-based HMIS, and nonphysician health workers' availability. However, strategies are needed to promote DM health workforce training, provide DM management guidelines, and ensure a reliable supply of essential DM medications.
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BACKGROUND: This study aims to understand and describe the clinical impact of SARS-CoV-2 (COVID-19) infection in patients with Hypertrophic Cardiomyopathy (HCM). METHODS: A data repository of over 6.6 million patients in a large metropolitan (Chicago IL) healthcare system was queried to identify adults with a history of HCM and COVID-19 infection between 2019 and 2021. Propensity score-matched analysis was performed based on age, sex, BMI, and elements of the cardiovascular history, including tobacco use, hypertension, hyperlipidemia, myocardial injury, and heart failure. RESULTS: Individuals with HCM and COVID-19 infection had more total hospitalizations (41.6 v 23 per 100 persons, p < 0.01), more heart-failure-related hospitalizations (24.2 v 8.7 per 100-persons, p < 0.01), more non-ST elevation myocardial injury (NSTEMI) hospitalizations (8.6 v 4.6 per 100-persons, p < 0.01), and increased mortality (10.8 v 5 per 100-persons, p < 0.01) compared to HCM patients without a history of COVID-19 infection. Patients with HCM and COVID-19 were also noted to have a higher peak CRP when compared to those without prior COVID-19 (Inter-quartile range of 9.0-106.9 v 1.8-21.3, p < 0.01). CONCLUSIONS: In patients with HCM, COVID-19 infection is associated with increased incidence of myocardial injury, increased number of total and heart-failure specific hospitalizations, and increased mortality.
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Background: Transcatheter mitral valve-in-valve (MViV) replacement has emerged as an alternative to redo mitral valve (MV) surgery for the management of failed bioprosthetic MVs. The degree of cardiac remodeling assessed by echocardiography has been shown to have prognostic implications in degenerative mitral regurgitation patients undergoing MV surgery. The impact of transcatheter MViV in patients with degenerative bioprosthetic MV failure on cardiac remodeling and its associated prognosis remains undescribed. Objectives: The aim of this study is to describe the early anatomic and functional changes of the left-sided chambers and right ventricle by echocardiography posttranscatheter MViV intervention and their impact on mortality outcomes. Additionally, we sought to analyze the outcome of heart failure in bioprosthetic MV failure patients undergoing transcatheter MViV replacement. Methods: We analyzed consecutive patients undergoing MViV intervention for symptomatic bioprosthetic MV failure. Echocardiograms before intervention and within 100 days postintervention were analyzed. A chart review was performed to obtain baseline characteristics, follow-up visits, 30-day heart failure and 1-year all-cause mortality outcomes. Results: A total of 62 patients (mean age 69 ± 13 years, 61% male) were included in the study. Most patients were undergoing MViV intervention for prosthetic mitral stenosis n = 48 (77.4%) and the rest for mitral regurgitation or mixed disease. Compared with baseline, significant reductions were observed in median left atrial volume (LAV; 103 [81-129] ml vs. 95.2 [74.5-117.5] ml, p < 0.01) and mean (SD) left atrial conduit strain (9.1% ± 5.2% vs. 10.8% ± 4.8%, p = 0.039) within 100 days postintervention. Early reduction in right ventricular free wall global longitudinal strain and fractional area change also occurred postintervention. No significant change in left ventricular chamber dimensions or ejection fraction was observed. During the 1-year follow up period, 5 (8%) patients died. While baseline LAV was not associated with 1-year all-cause mortality (OR 0.98 CI 0.95-1.01; p = 0.27), a change in LAV in the follow up period was associated with all-cause mortality at 1 year (OR 1.06 CI 1.01-1.12; p = 0.023). At 30 days postintervention, 65% of patients had an improvement in their New York Heart Association functional class. Conclusion: In this retrospective study of patients undergoing transcatheter MViV intervention for failed bioprosthetic MVs, early reverse remodeling of the left atrium occurs within 100 days postintervention and reduction in LAV is associated with reduced all-cause mortality at 1 year. In addition, there is significant improvement in heart failure symptoms at 30 days following intervention but further investigation into the longitudinal remodeling changes and long-term outcomes is needed.
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BACKGROUND: Regular engagement over time in hypertension care, or retention, is a crucial but understudied step in optimizing patient outcomes. This systematic review leverages a hermeneutic methodology to identify, evaluate, and quantify the effects of interventions and contextual factors for improving retention for patients with hypertension. METHODS: We searched for articles that were published between 2000 and 2022 from multiple electronic databases, including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and WHO International Trials Registry. We followed the latest version of the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline to report the findings for this review. We also synthesized the findings using a hermeneutic methodology for systematic reviews, which used an iterative process to review, integrate, analyze, and interpret evidence. RESULTS: From 4686 screened titles and abstracts, 18 unique studies from 9 countries were identified, including 10 (56%) randomized controlled trials (RCTs), 3 (17%) cluster RCTs, and 5 (28%) non-RCT studies. The number of participants ranged from 76 to 1562. The overall mean age range was 41-67 years, and the proportion of female participants ranged from 0% to 100%. Most (n = 17, 94%) studies used non-physician personnel to implement the proposed interventions. Fourteen studies (78%) implemented multilevel combinations of interventions. Education and training, team-based care, consultation, and Short Message Service reminders were the most common interventions tested. CONCLUSIONS: This review presents the most comprehensive findings on retention in hypertension care to date and fills the gaps in the literature, including the effectiveness of interventions, their components, and contextual factors. Adaptation of and implementing HIV care models, such differentiated service delivery, may be more effective and merit further study. REGISTRATION: CRD42021291368. PROTOCOL REGISTRATION: PROSPERO 2021 CRD42021291368. Available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=291368.
Subject(s)
Hypertension , Primary Health Care , Humans , Hypertension/therapy , Retention in Care , HermeneuticsSubject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Pulmonary Artery/diagnostic imaging , Pulmonary Artery/surgery , Treatment Outcome , Prosthesis Failure , Cardiac Catheterization , Prosthesis DesignABSTRACT
Advances in left ventricular assist device technologies have led to an improvement in pump hemocompatibility and outcomes. Because of concerns of thromboembolic complications in prior generations of left ventricular assist devices, bridging with parenteral anticoagulants was routinely. Management strategies of subtherapeutic INRs and their effects on the current generation of devices deserve review. We performed analysis of the MOMENTUM 3 trial including 6 centers in the mid-America region. Patients with subtherapeutic INRs (INR < 2) occurring after the index admission underwent chart review to determine the management strategies taken by clinicians. Strategies were divided into two groups, bridging or nonbridging. Of the 225 patients included in the analysis, 130 (58%) patients had a total of 235 subtherapeutic international normalized ratio (INR) events. Most (n = 179, 76.2%) of these INRs were not bridged (n = 100 warfarin dose adjustment, n = 79 no change in warfarin dose). Among those INRs (n = 56, 23.8%) treated with bridging, approximately half (n = 30, 53.6%) were treated with subcutaneous agents and other half (n = 26, 46.4%) were treated with intravenous agents. There was no difference in individual outcomes or composite endpoints of death, rehospitalization, CVA, or bleeding events between the groups.
Subject(s)
Heart-Assist Devices , Thromboembolism , Humans , Warfarin/therapeutic use , Heart-Assist Devices/adverse effects , Anticoagulants/therapeutic use , Thromboembolism/etiology , Thromboembolism/prevention & control , Hemorrhage/etiology , International Normalized Ratio , Retrospective StudiesABSTRACT
BACKGROUND: Cardiovascular events, including heart failure and arrhythmias, following chimeric antigen receptor (CAR) T-cell therapy are increasingly recognized. Although global longitudinal strain (GLS) has demonstrated prognostic utility for other cancer therapy-related cardiac dysfunction, less is known regarding the association of GLS with adverse cardiac events following CAR T-cell therapy. OBJECTIVES: To determine the association of baseline GLS with adverse cardiovascular events in adults receiving CAR-T cell therapy. METHODS: Patients who had an echocardiogram within 6 months prior to receiving CAR T-cell therapy were retrospectively identified. Clinical data and cardiac events were collected via chart review. Echocardiograms were analyzed offline for GLS, left ventricular ejection fraction, and Doppler parameters. Multivariable logistic regression was used to determine the association between adverse cardiovascular events and echocardiographic parameters. RESULTS: Among 75 CAR T-cell therapy patients (mean age 63.9, 34.7% female), nine patients (12%) experienced cardiac events (CEs) including cardiovascular death, new/worsening heart failure, and new/worsening arrhythmia within 1 year of treatment. In univariable models, higher baseline GLS (OR 0.78 [0.63, 0.96], p = .021) was associated with a lower risk of CE and higher baseline mitral E/e' (OR 1.40 [1.08, 1.81], p = .012) was associated with a higher risk of CE. After adjusting for age and LDH, higher baseline GLS (OR 0.65 [0.48-0.88], p = <.01) was associated with a lower risk of CE and higher baseline mitral E/e' (OR 1.56 [1.06, 2.29], p = .024) was associated with a higher risk of CE. CONCLUSION: Lower GLS and higher mitral E/e' on a baseline echocardiogram were associated with higher risk for CEs in patients receiving CAR T-cell therapy.
Subject(s)
Heart Failure , Receptors, Chimeric Antigen , Ventricular Dysfunction, Left , Adult , Humans , Female , Male , Ventricular Function, Left , Stroke Volume/physiology , Retrospective Studies , Immunotherapy, Adoptive/adverse effects , Heart Failure/diagnosis , Heart Failure/etiology , Heart Failure/therapy , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/therapy , Cell- and Tissue-Based Therapy , Ventricular Dysfunction, Left/diagnosis , Ventricular Dysfunction, Left/etiology , Ventricular Dysfunction, Left/therapyABSTRACT
For ibrutinib-related atrial fibrillation (IRAF), guidelines for anticoagulation do not exist. We sought to describe stroke, bleeding, and anticoagulation rates among patients with IRAF. We performed a single-center retrospective review of 168 patients treated with ibrutinib followed from 2013 to 2022. Over a median follow-up of 6.4 years, 44 (26.0%) patients developed IRAF of which 38 (86.4%) had a CHA2DS2-VASc ≥2 and 7 (15.9%) had a HAS-BLED ≥3. Anticoagulation was initiated in 20 (45.5%) without a clear pattern in scores, risk factors, or cumulative dose, besides having another reason for anticoagulation. Few patients with IRAF developed non-hemorrhagic CVA (n = 3, 6.8%) or significant bleeding (n = 3, 6.8%). Among those with each adverse outcome, 2 in each group were anticoagulated and all were older than 65 years old. In conclusion, decisions for anticoagulation vary widely and patients who are elderly or with HTN may be most at risk for CVA or significant bleed.
Subject(s)
Adenine/analogs & derivatives , Atrial Fibrillation , Piperidines , Stroke , Humans , Aged , Atrial Fibrillation/complications , Anticoagulants/therapeutic use , Risk Assessment , Blood Coagulation , Stroke/etiology , Hemorrhage/etiology , Risk FactorsABSTRACT
BACKGROUND: This convergent parallel-design mixed-methods process evaluation of the QUARTET USA (Quadruple Ultra-Low-Dose Treatment for Hypertension USA) clinical trial (NCT03640312) explores patient and health care professional perceptions about the use of low-dose quadruple therapy (LDQT) as a novel strategy for hypertension management. METHODS AND RESULTS: A survey of all 62 patients enrolled in the QUARTET USA trial was conducted. A subsample of 13 patients and 11 health care professionals, recruited via purposive sampling, took part in semistructured interviews. At enrollment, 68% of participants (mean [SD] age, 51.7 [11.5] years; 56% self-identified as Hispanic: Mexican ethnicity, 16% as Hispanic: other ethnicity, 16% as Black race, 8% as White race, and 1.6% as South Asian race) reported that their current health depended on blood pressure medications, and 48% were concerned about blood pressure medications. At trial completion, 80% were satisfied with LDQT, 96% were certain the benefits of taking LDQT outweighed the disadvantages, and 96% reported that LDQT was convenient to take. Both patients and health care professionals found LDQT acceptable because it reduced patients' perceived pill burden and facilitated medication adherence. Health care professionals stated that a perceived limitation of LDQT was the inability to titrate doses. Steps to facilitate LDQT implementation include introducing stepped-care combinations and treatment protocols, inclusion in clinical practice guidelines, and eliminating patient cost barriers. CONCLUSIONS: LDQT was an acceptable strategy for hypertension treatment among patients and health care professionals involved in the QUARTET USA clinical trial. Although LDQT was generally perceived as beneficial for maintaining patients' blood pressure control and facilitating adherence, some clinicians perceived limitations in titration inflexibility, adverse effects, and costs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03640312.
Subject(s)
Hypertension , Humans , Middle Aged , Antihypertensive Agents/adverse effects , Blood Pressure , Double-Blind Method , Hypertension/drug therapy , Medication Adherence , AdultABSTRACT
Background: The Extension for Community Health Outcomes (ECHO) model has been used extensively to link care providers in rural communities with experts with the aim of improving local patient care. Objective: The aim of this qualitative research study was to assess the feasibility, acceptability, perceived needs, and contextual factors to guide implementation of a hypertension focused ECHO program for Community Health Extension Workers (CHEWs) in the Federal Capital Territory, Nigeria. Methods: From September 2020 to December 2020, key informant interviews were performed with seven global organizations (hubs) providing ECHO training focused on cardiovascular disease or nephrology to identify contextual factors and implementation strategies used by each hub. In February 2022, seven focus group discussions were performed with 42 frontline healthcare workers in the Federal Capital Territory to inform local adaptation of a hypertension ECHO program. Directed content analysis identified major themes which were mapped to the Consolidated Framework for Implementation Research. Qualitative analyses were performed using Dedoose, and results were synthesized using the Implementation Research Logic Model. Results: We found both barriers and facilitators across the Consolidated Framework for Implementation Research domains that mapped to a number of constructs in each one. The results of these analyses confirmed that the core components of the ECHO model are a feasible and appropriate intervention for hypertension education of healthcare workers. However, implementing the ECHO program within the Federal Capital Territory may require strategies such as utilizing communications resources effectively, developing incentives to motivate initial participation, and providing rewards or recognition for ongoing engagement. Conclusions: These results provide valuable formative insights to guide implementation of our proposed hypertension ECHO program for CHEWs in the Federal Capital Territory, Nigeria. This information was used for key decisions around: 1) scope and content of training, 2) format and frequency, 3) selection of implementation strategies, and 4) building a community of practice.
Subject(s)
Hypertension , Public Health , Humans , Nigeria , Health Personnel , Qualitative Research , Community Health WorkersABSTRACT
BACKGROUND: People with heart failure (HF) and cancer experience impaired physical and mental health status. However, health-related quality of life (HRQOL) has not been directly compared between these conditions in a contemporary population of older people. OBJECTIVES: The authors sought to compare HRQOL in people with HF vs those with lung, colorectal, breast, and prostate cancers. METHODS: The authors performed a pooled analysis of Medicare Health Outcomes Survey data from 2016 to 2020 in participants ≥65 years of age with a self-reported history of HF or active treatment for lung, colon, breast, or prostate cancer. They used the Veterans RAND-12 physical component score (PCS) and mental component score (MCS), which range from 0-100 with a mean score of 50 (based on the U.S. general population) and an SD of 10. The authors used pairwise Student's t-tests to evaluate for differences in PCS and MCS between groups. RESULTS: Among participants with HF (n = 71,025; 54% female, 16% Black), mean PCS was 29.5 and mean MCS 47.9. Mean PCS was lower in people with HF compared with lung (31.2; n = 4,165), colorectal (35.6; n = 4,270), breast (37.7; n = 14,542), and prostate (39.6; n = 17,670) cancer (all P < 0.001). Participants with HF had a significantly lower mean MCS than those with lung (31.2), colon (50.0), breast (52.0), and prostate (53.0) cancer (all P < 0.001). CONCLUSIONS: People with HF experience worse HRQOL than those with cancer actively receiving treatment. The pervasiveness of low HRQOL in HF underscores the need to implement evidence-based interventions that target physical and mental health status and scale multidisciplinary clinics.
ABSTRACT
OBJECTIVE: Guideline recommendations for mechanical or bioprosthetic valve for mitral valve replacement by age remains controversial. We sought to determine bovine pericardial valve durability by age and risk of reintervention. METHODS: This retrospective study between 2 large university-based cardiac surgery programs examined patients who underwent bioprosthetic mitral valve replacement from 2004 to 2020. Follow-up was obtained through June 2022. Durability outcomes involving structural valve deterioration were compared by age decile. RESULTS: Of 1544 available patients, mean age was 66 ± 13 years and 652 (42%) were aged less than 65 years. Indications for mitral valve replacement were as follows: mitral regurgitation greater than 2+ in 53% (n = 813), mitral stenosis in 44% (n = 650), endocarditis in 18% (n = 277), and reoperation in 39% (n = 602). Concomitant procedures were aortic valve replacement in 28% (n = 426), tricuspid valve in 36% (n = 550), and coronary artery bypass in 19% (n = 290). Thirty-day mortality was 5.4%. In follow-up (clinical: median [interquartile range] 75 [25-129] months), reoperation for endocarditis and new stroke were low (0.30 and 1.06 per 100 patient/years, respectively). The cumulative incidence of mitral valve reintervention for structural valve deterioration among all patients was 6.2% at 10 years and 9.0% at 12 years with no statistical difference in structural valve deterioration in patients aged 40 to 70 years (P = .1). In 90 patients with mitral valve reintervention, 30-day mortality after reintervention was 4.7% (n = 2) for 43 with mitral valve-in-valve and 6.4% (n = 3) for 47 with reoperation. CONCLUSIONS: Bovine pericardial mitral valve replacement is a durable option for younger patients. The opportunity to avoid anticoagulation and the associated risks with mechanical mitral valve replacement may be of benefit to patients. These insights may provide data needed to revise the current guidelines.
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BACKGROUND: Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology. OBJECTIVES: This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology. METHODS: A total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics. RESULTS: Median age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%). CONCLUSIONS: The majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions.