Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 23
Filter
1.
J Card Fail ; 30(2): 391-398, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37806488

ABSTRACT

There is waning interest among cardiology trainees in pursuing an Advanced Heart Failure/Transplant Cardiology (AHFTC) fellowship as evidenced by fewer applicants in the National Resident Matching Program match to this specialty. This trend has generated considerable attention across the heart failure community. In response, the Heart Failure Society of America convened the AHFTC Fellowship Task Force with a charge to develop strategies to increase the value proposition of an AHFTC fellowship. Subsequently, the HFSA sponsored the AHFTC Fellowship Consensus Conference April 26-27, 2023. Before the conference, interviews of 44 expert stakeholders diverse across geography, site of practice (traditional academic medical center or other centers), specialty/area of expertise, sex, and stage of career were conducted virtually. Based on these interviews, potential solutions to address the declining interest in AHFTC fellowship were categorized into five themes: (1) alternative training pathways, (2) regulatory and compensation, (3) educational improvements, (4) exposure and marketing for pipeline development, and (5) quality of life and mental health. These themes provided structure to the deliberations of the AHFTC Fellowship Consensus Conference. The recommendations from the Consensus Conference were subsequently presented to the HFSA Board of Directors to inform strategic plans and interventions. The HFSA Board of Directors later reviewed and approved submission of this document. The purpose of this communication is to provide the HF community with an update summarizing the processes used and concepts that emerged from the work of the HFSA AHFTC Fellowship Task Force and Consensus Conference.


Subject(s)
Cardiology , Heart Failure , Humans , Heart Failure/diagnosis , Heart Failure/surgery , Fellowships and Scholarships , Quality of Life , Consensus
2.
N Engl J Med ; 380(17): 1618-1627, 2019 04 25.
Article in English | MEDLINE | ID: mdl-30883052

ABSTRACT

BACKGROUND: In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS: We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS: This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS: Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).


Subject(s)
Heart Failure/therapy , Heart-Assist Devices , Prosthesis Design , Adolescent , Adult , Aged , Aged, 80 and over , Disease-Free Survival , Female , Heart-Assist Devices/adverse effects , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Middle Aged , Prosthesis Failure , Reoperation/statistics & numerical data , Stroke/etiology
3.
J Heart Lung Transplant ; 38(9): 920-926, 2019 09.
Article in English | MEDLINE | ID: mdl-30898555

ABSTRACT

BACKGROUND: After 3 years of continuous-flow left ventricular assist device (CF-LVAD) support, nearly a third of patients develop at least moderate aortic insufficiency (AI). Percutaneous occluder devices, surgical aortic valve replacement (SAVR), and urgent heart transplantation are available treatment options. Transcatheter aortic valve replacement (TAVR) has not been widely used for treating symptomatic AI in patients on LVAD support. METHODS: Retrospective chart review and data analysis from October 2010 through August 2017 was performed. A total of 286 patients with end-stage heart failure (ESHF) were implanted with a durable CF-LVAD. Nine patients subsequently developed significant symptomatic AI, which was treated with TAVR. RESULTS: All 9 patients had 1 TAVR procedure with resolution of AI and were discharged home. Procedural complications include valve migration warranting a second valve for stabilization, retroperitoneal and groin hematoma, and pseudoaneurysm requiring thrombin injection. A significant improvement of the New York Heart Association classification was noted from the time of implant to 6 months. Two patients had unplanned heart failure‒related hospitalizations within 6 months. At 6 months, 89% of patients were alive on LVAD support. CONCLUSIONS: TAVR is a successful treatment modality for LVAD patients who develop symptomatic AI.


Subject(s)
Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/surgery , Heart-Assist Devices/adverse effects , Transcatheter Aortic Valve Replacement , Adult , Aged , Aortic Valve Insufficiency/diagnosis , Female , Heart Failure/surgery , Humans , Male , Middle Aged , Retrospective Studies , Time Factors , Treatment Outcome
4.
N Engl J Med ; 378(15): 1386-1395, 2018 Apr 12.
Article in English | MEDLINE | ID: mdl-29526139

ABSTRACT

BACKGROUND: In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. METHODS: In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points. RESULTS: Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). CONCLUSIONS: In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).


Subject(s)
Heart Failure/therapy , Heart-Assist Devices , Prosthesis Design , Adult , Aged , Aged, 80 and over , Blood Pressure , Female , Heart Failure/mortality , Heart Failure/physiopathology , Heart-Assist Devices/adverse effects , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Middle Aged , Quality of Life , Reoperation/statistics & numerical data , Stroke/epidemiology , Stroke/etiology , Stroke/mortality , Thrombosis/etiology , Treatment Outcome , Walk Test
5.
J Am Heart Assoc ; 7(3)2018 02 03.
Article in English | MEDLINE | ID: mdl-29431103

ABSTRACT

BACKGROUND: Higher body mass index (BMI) is associated with lower circulating levels of N-terminal-pro-b-type natriuretic peptide (NT-proBNP). The Interaction between BMI and NT-proBNP with respect to clinical outcomes is not well characterized in patients with acute heart failure. METHODS AND RESULTS: A total of 686 patients from the biomarker substudy of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated HF ) clinical trial with documented NT-proBNP levels at baseline were included in the present analysis. Patients were classified by the World Health Organization obesity classification (nonobese: BMI <30 kg/m2, Class I obesity: BMI 30-34.9 kg/m2, Class II obesity BMI 35-39.9 kg/m2, and Class III obesity BMI ≥40 kg/m2). We assessed baseline characteristics and 30- and 180-day outcomes by BMI class and explored the interaction between BMI and NT-proBNP for these outcomes. Study participants had a median age of 67 years (55, 78) and 71% were female. NT-proBNP levels were inversely correlated with BMI (P<0.001). Higher NT-proBNP levels were associated with higher 180-day mortality (adjusted hazard ratio for each doubling of NT-proBNP, 1.40; 95% confidence interval, 1.16, 1.71; P<0.001), but not 30-day outcomes. The effect of NT-proBNP on 180-day death was not modified by BMI class (interaction P=0.24). CONCLUSIONS: The prognostic value of NT-proBNP was not modified by BMI in this acute heart failure population. NT-proBNP remains a useful prognostic indicator of long-term mortality in acute heart failure even in the obese patient. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.


Subject(s)
Body Mass Index , Heart Failure/blood , Heart Failure/mortality , Natriuretic Peptide, Brain/blood , Obesity/blood , Obesity/mortality , Peptide Fragments/blood , Acute Disease , Aged , Biomarkers/blood , Heart Failure/diagnosis , Heart Failure/drug therapy , Humans , Middle Aged , Natriuretic Agents/therapeutic use , Natriuretic Peptide, Brain/therapeutic use , Obesity/diagnosis , Peptide Fragments/therapeutic use , Prognosis , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Time Factors
6.
J Am Coll Cardiol ; 70(3): 331-341, 2017 Jul 18.
Article in English | MEDLINE | ID: mdl-28705314

ABSTRACT

BACKGROUND: Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life. OBJECTIVES: The authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes. METHODS: The authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT-Spiritual Well-Being scale [FACIT-Sp]), hospitalizations, and mortality. RESULTS: Patients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT-Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT-Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = -1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = -1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT-Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality. CONCLUSIONS: An interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart Failure [PAL-HF]; NCT01589601).


Subject(s)
Heart Failure/therapy , Palliative Care/methods , Quality of Life , Aged , Female , Follow-Up Studies , Heart Failure/diagnosis , Humans , Male , Prospective Studies , Severity of Illness Index , Treatment Outcome
7.
JAMA Cardiol ; 2(7): 750-757, 2017 07 01.
Article in English | MEDLINE | ID: mdl-28538984

ABSTRACT

Importance: Pragmatic clinical trial designs have proposed the use of medical claims data to ascertain clinical events; however, the accuracy of billed diagnoses in identifying potential events is unclear. Objectives: To compare the 1-year cumulative incidences of events when events were identified by medical claims vs by physician adjudication and to assess the accuracy of bill-identified events using physician adjudication as the criterion standard. Design, Setting, and Participants: This post hoc analysis of a clinical trial assessed the medical claims forms and records for all rehospitalizations at 233 US hospitals within 1 year of the index acute myocardial infarction (MI) of 12 365 patients enrolled in the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) study between April 1, 2010, and October 31, 2012. Fourteen patients (0.1%) died during the index hospitalization and were excluded from analysis. Recurrent MI, stroke, and bleeding events were identified per the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedural codes in medical bills. These events were independently adjudicated by study physicians through medical record reviews using the prespecified criteria of recurrent MI and stroke and the bleeding definition by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scale. Medical claims were reported on a Uniform Bill-04 claims form; claims were collected from all hospitals visited by patients enrolled in TRANSLATE-ACS. Agreement between medical claims-identified events and physician-adjudicated events over the 12 months after discharge was assessed with the κ statistic. Data were analyzed from January 30, 2015, to March 2, 2017. Main Outcomes and Measures: Event rates within 1 year after MI. Results: Among 12 365 patients with acute MI, 8890 (71.9%) were men and mean (SD) age was 60 (11.6) years. The cumulative 1-year incidence of events identified by medical claims was 4.3% for MI, 0.9% for stroke, and 5.0% for bleeding. Incidence rates based on physician adjudication were 4.7% for MI, 0.9% for stroke, and 5.4% for bleeding. Agreement between medical claims-identified and physician-adjudicated events was modest, with a κ of 0.76 (95% CI, 0.73 to 0.79) for MI and 0.55 (95% CI, 0.41 to 0.68) for stroke events. In contrast, agreement between medical claims-identified and physician-adjudicated bleeding events was poor, with a κ of 0.24 (95% CI, 0.19 to 0.30) for any hospitalized bleeding event and 0.15 (95% CI, 0.11 to 0.20) for moderate or severe bleeding on the GUSTO scale. Conclusions and Relevance: Event rates at 1 year after MI were lower for MI, stroke, and bleeding when medical claims were used to identify events than when adjudicated by physicians. Medical claims diagnoses were only modestly accurate in identifying MI and stroke admissions but had limited accuracy for bleeding events. An alternative approach may be needed to ensure good safety surveillance in cardiovascular studies. Trial Registration: clinicaltrials.gov Identifier: NCT01088503.


Subject(s)
Acute Coronary Syndrome/epidemiology , Administrative Claims, Healthcare , Hemorrhage/epidemiology , Myocardial Infarction/epidemiology , Stroke/epidemiology , Aged , Data Collection , Databases, Factual , Female , Hospitalization , Humans , Incidence , Male , Middle Aged , Patient Readmission , Recurrence , United States/epidemiology
8.
Clin Transplant ; 31(5)2017 05.
Article in English | MEDLINE | ID: mdl-28294407

ABSTRACT

BACKGROUND: Cardiac allografts are routinely evaluated by left ventricular ejection fraction (LVEF) before and after transplantation. However, myocardial deformation analyses with LV global longitudinal strain (GLS) are more sensitive for detecting impaired LV myocardial systolic performance compared with LVEF. METHODS: We analyzed echocardiograms in 34 heart donor-recipient pairs transplanted at Duke University from 2000 to 2013. Assessments of allograft LV systolic function by LVEF and/or LV GLS were performed on echocardiograms obtained pre-explanation in donors and serially in corresponding recipients. RESULTS: Donors had a median LVEF of 55% (25th, 75th percentile, 54% to 60%). Median donor LV GLS was -14.6% (-13.7 to -17.3%); LV GLS was abnormal (ie, >-16%) in 68% of donors. Post-transplantation, LV GLS was further impaired at 6 weeks (median -11.8%; -11.0 to -13.4%) and 3 months (median -11.4%; -10.3 to -13.9%) before recovering to pretransplant levels in follow-up. Median LVEF remained ≥50% throughout follow-up. We found no association between donor LV GLS and post-transplant outcomes, including all-cause hospitalization and mortality. CONCLUSIONS: GLS demonstrates allograft LV systolic dysfunction in donors and recipients not detected by LVEF. The clinical implications of subclinical allograft dysfunction detected by LV GLS require further study.


Subject(s)
Heart Failure, Systolic/physiopathology , Tissue Donors , Ventricular Dysfunction, Left/physiopathology , Adult , Allografts , Echocardiography/methods , Female , Follow-Up Studies , Heart Failure, Systolic/diagnostic imaging , Humans , Male , Middle Aged , Prognosis , Prospective Studies , Retrospective Studies , Stroke Volume , Transplant Recipients , Ventricular Dysfunction, Left/diagnostic imaging , Young Adult
9.
Eur Heart J Acute Cardiovasc Care ; 6(8): 709-718, 2017 Dec.
Article in English | MEDLINE | ID: mdl-27230622

ABSTRACT

BACKGROUND: Intra-aortic balloon pumps (IABPs) provide primarily left ventricular support, yet few data detail the efficacy of this temporary mechanical circulatory support device in patients with concomitant right ventricular failure. We compared the efficacy of IABPs in cardiogenic shock patients with isolated left ventricular versus biventricular failure. METHODS: IABP-treated cardiogenic shock patients were identified from our center between 2006 and 2012, with patients stratified by either isolated left ventricular failure or biventricular failure. We compared baseline characteristics and 72-hour and 30-day outcomes between groups. Outcomes of interest included escalation of mechanical circulatory support, a clinical definition of IABP failure, and death. RESULTS: Among 107 patients, 60 patients (56%) had isolated left ventricular failure compared with 47 patients (44%) having biventricular failure. Patients with isolated left ventricular failure were older and more likely to have coronary artery disease ( p<0.05, both). Patients with biventricular failure more often required escalation of mechanical circulatory support at both 72 hours (21% vs. 2%, p<0.001) and 30 days (36% vs. 30%). However, there was no significant difference between groups for failure of IABP therapy at 72 hours ( p=0.27) or at 30 days ( p=0.62) and death at 30 days ( p=0.98). In adjusted analysis, there was no significant difference between groups with regard to risk for a clinical definition of IABP failure at 30 days (odds ratio=0.85, 95% confidence interval (0.27, 2.69)). CONCLUSIONS: IABP-treated cardiogenic shock patients with biventricular failure more often required early escalation of mechanical circulatory support. However, there were no significant differences by type of ventricular failure with regard to 30-day outcomes.


Subject(s)
Heart Failure/therapy , Heart Ventricles/physiopathology , Intra-Aortic Balloon Pumping/methods , Ventricular Dysfunction, Right/therapy , Ventricular Function, Right/physiology , Adult , Aged , Cardiac Catheterization , Cause of Death/trends , Echocardiography , Female , Heart Failure/etiology , Heart Failure/mortality , Heart Ventricles/diagnostic imaging , Hospital Mortality/trends , Humans , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , Survival Rate/trends , Treatment Outcome , United States/epidemiology , Ventricular Dysfunction, Right/complications , Ventricular Dysfunction, Right/mortality
10.
Curr Cardiol Rep ; 18(10): 101, 2016 10.
Article in English | MEDLINE | ID: mdl-27568795

ABSTRACT

In patients with atrial fibrillation (AF), oral anticoagulation is used to prevent stroke and systemic embolism. In a common clinical scenario, AF patients frequently undergo invasive procedures requiring temporary interruption of oral anticoagulation, thereby potentially exposing such patients to increased risk of thromboembolism. Bridging anticoagulation has been used clinically to mitigate this perceived thromboembolic risk, though this practice may also increase risk of periprocedural bleeding. High-quality data has not previously existed to inform decision-making in this clinical situation of bridging anticoagulation. We discuss recent results from the BRIDGE trial and secondary analyses from recent phase 3 randomized clinical trials of direct-acting oral anticoagulant (DOAC) use in non-valvular AF, that inform periprocedural anticoagulation with bridging strategies in AF patients. Updated data from these current trials favor against a strategy of bridging anticoagulation for elective procedures in the majority of AF patients, low or moderate in thromboembolic risk. Bridging anticoagulation is associated with an increased risk of bleeding and no decreased risk of thromboembolism.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Stroke/prevention & control , Thromboembolism/prevention & control , Administration, Oral , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Drug Administration Schedule , Humans , Perioperative Care , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Treatment Outcome
11.
J Card Fail ; 22(8): 589-97, 2016 Aug.
Article in English | MEDLINE | ID: mdl-26975941

ABSTRACT

BACKGROUND: Higher rates of obesity and heart failure have been observed in African Americans, but associations with mortality are not well-described. We examined intermediate and long-term clinical implications of obesity in African Americans and associations between obesity and all-cause mortality, heart failure, and heart failure hospitalization. METHODS AND RESULTS: We conducted a retrospective analysis of a community sample of 5292 African Americans participating in the Jackson Heart Study between September 2000 and January 2013. The main outcomes were associations between body mass index (BMI) and all-cause mortality at 9 years and heart failure hospitalization at 7 years using Cox proportional hazards models and interval development of heart failure (median 8 years' follow-up) using a modified Poisson model. At baseline, 1406 (27%) participants were obese and 1416 (27%) were morbidly obese. With increasing BMI, the cumulative incidence of mortality decreased (P= .007), whereas heart failure increased (P < .001). Heart failure hospitalization was more common among morbidly obese participants (9.0%; 95% confidence interval [CI] 7.6-11.7) than among normal-weight patients (6.3%; 95% CI 4.7-8.4). After risk adjustment, BMI was not associated with mortality. Each 1-point increase in BMI was associated with a 5% increase in the risk of heart failure (hazard ratio 1.05; 95% CI 1.03-1.06; P < .001) and the risk of heart failure hospitalization for BMI greater than 32 kg/m(2) (hazard ratio 1.05; 95% CI 1.03-1.07; P < .001). CONCLUSIONS: Obesity and morbid obesity were common in a community sample of African Americans, and both were associated with increased heart failure and heart failure hospitalization.


Subject(s)
Black or African American , Body Mass Index , Healthcare Disparities , Heart Failure/ethnology , Hospitalization/trends , Obesity, Morbid/ethnology , Risk Assessment , Adult , Aged , Cause of Death/trends , Female , Follow-Up Studies , Heart Failure/complications , Heart Failure/therapy , Humans , Male , Middle Aged , North Carolina/epidemiology , Obesity, Morbid/complications , Proportional Hazards Models , Prospective Studies , Risk Factors , Survival Rate/trends
12.
J Am Heart Assoc ; 5(1)2016 Jan 25.
Article in English | MEDLINE | ID: mdl-26811163

ABSTRACT

BACKGROUND: Longitudinal clinical investigations often rely on patient reports to screen for postdischarge adverse outcomes events, yet few studies have examined the accuracy of such patient reports. METHODS AND RESULTS: Patients with acute myocardial infarction (MI) in the TRANSLATE-ACS study were asked during structured interviews at 6 weeks, 6 months, and 12 months postdischarge to report any rehospitalizations. The accuracy of patient-reported rehospitalizations within 1 year of postdischarge was determined using claims-based medical bill validation as the reference standard. The cumulative incidence of rehospitalizations was compared when identified by patient report versus medical bills. Patients were categorized by the accuracy in reporting events (accurate, under-, or over- reporters) and characteristics were compared between groups. Among 10 643 MI patients, 4565 (43%) reported 7734 rehospitalizations. The sensitivity and positive predictive value of patient-reported rehospitalizations were low at 67% and 59%, respectively. A higher cumulative incidence of rehospitalization was observed when identified by patient report versus medical bills (43% vs 37%; P<0.001). Overall, 18% of patients over-reported and 10% under-reported the number of hospitalizations. Compared with accurate reporters, under-reporters were more likely to be older, female, African American, unemployed, or a non-high-school graduate, and had greater prevalence of clinical comorbidities such as diabetes and past cardiovascular disease. CONCLUSIONS: The accuracy of patient-reported rehospitalizations was low with patients both under- and over-reporting events. Longitudinal clinical research studies need additional mechanisms beyond patient report to accurately identify rehospitalization events. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01088503.


Subject(s)
Myocardial Infarction/therapy , Patient Outcome Assessment , Patient Readmission , Research Design , Self Report , Aged , Female , Health Care Costs , Hospital Charges , Humans , Male , Middle Aged , Myocardial Infarction/diagnosis , Patient Discharge , Reproducibility of Results , Risk Factors , Time Factors , United States
13.
Heart Fail Clin ; 11(4): 581-9, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26462098

ABSTRACT

Although the prognosis of ambulatory heart failure (HF) has improved dramatically there have been few advances in the management of acute HF (AHF). Despite regional differences in patient characteristics, background therapy, and event rates, AHF clinical trial enrollment has transitioned from North America and Western Europe to Eastern Europe, South America, and Asia-Pacific where regulatory burden and cost of conducting research may be less prohibitive. It is unclear if the results of clinical trials conducted outside of North America are generalizable to US patient populations. This article uses AHF as a paradigm and identifies barriers and practical solutions to successfully conducting site-based research in North America.


Subject(s)
Clinical Trials as Topic/economics , Clinical Trials as Topic/legislation & jurisprudence , Heart Failure/therapy , Research Design/standards , Research/economics , Research/legislation & jurisprudence , Acute Disease , Clinical Trials as Topic/ethics , Guideline Adherence , Humans , North America , Research Design/trends
14.
Am J Cardiol ; 116(4): 573-9, 2015 Aug 15.
Article in English | MEDLINE | ID: mdl-26092273

ABSTRACT

Alternatives have emerged for patients ineligible for cardiac transplantation under standard criteria. The purpose of our study was to compare outcomes in patients ineligible for cardiac transplantation under standard criteria, treated either with extended criteria cardiac transplantation (ECCT) or a continuous flow destination therapy left ventricular assist device (CF DT-LVAD). From 2005 to 2012, patients treated with either ECCT or CF DT-LVAD at our institution were retrospectively analyzed. In the overall unmatched cohort, we examined mortality and other outcomes, including index hospitalization length of stay, renal function, stroke, and readmission rates. After propensity score (PS) matching, outcomes were compared between ECCT and CF DT-LVAD recipients. Overall, 62 patients underwent ECCT, and 146 patients were treated with CF DT-LVAD. The 2-year mortality estimate for ECCT recipients was 27.3% (95% confidence interval 15.5% to 39.1%) and for CF DT-LVAD recipients was 11.2% (95% confidence interval 4.8% to 17.6%). After PS matching of 39 patients from each treatment group, there was no significant difference in overall survival after 2 years (p = 0.346). In both unmatched and PS-matched analyses, CF DT-LVAD patients compared with ECCT had a significantly higher estimated glomerular filtration rate at 1 year but also had significantly higher hospital readmission rates. Stroke also more commonly occurred after CF DT-LVAD compared with ECCT (17 vs 5, unmatched; and 2 vs 1, PS matched). However, there was no significant difference between PS-matched groups in 2-year stroke-free survival (p = 0.371). In conclusion, ECCT and CF DT-LVAD in select patients are comparable therapies with respect to 2-year survival.


Subject(s)
Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices , Aged , Female , Glomerular Filtration Rate , Heart Failure/complications , Heart Failure/mortality , Hospitalization , Humans , Male , Middle Aged , Patient Selection , Retrospective Studies , Stroke/epidemiology , Survival Analysis , Time Factors , Treatment Outcome
16.
Am Heart J ; 169(3): 315-22, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25728720

ABSTRACT

The novel oral anticoagulants (NOACs) have rapidly emerged as an alternative therapy to warfarin. Several recent phase 3 randomized control trials have demonstrated the efficacy and safety of the NOACs in the treatment for patients with nonvalvular atrial fibrillation. As the NOACs are incorporated in clinical practice, questions have begun to arise concerning their optimal use in commonly encountered situations. In this review, we provide a summary of the available evidence from the phase 3 randomized control trials specifically with regard to 1 such scenario, the periprocedural management of NOACs, with a goal of providing guidance for practicing clinicians.


Subject(s)
Anticoagulants/therapeutic use , Antithrombins/therapeutic use , Atrial Fibrillation/drug therapy , Administration, Oral , Anticoagulants/administration & dosage , Antithrombins/administration & dosage , Benzimidazoles/therapeutic use , Clinical Trials, Phase III as Topic , Dabigatran , Factor Xa Inhibitors/therapeutic use , Humans , Morpholines/therapeutic use , Rivaroxaban , Thiophenes/therapeutic use , Treatment Outcome , beta-Alanine/analogs & derivatives , beta-Alanine/therapeutic use
17.
Am Heart J ; 168(6): 891-900, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25458653

ABSTRACT

BACKGROUND: Transient and persistent worsening renal function (WRF) may be associated with different risks during hospitalization for acute heart failure. We compared outcomes of patients hospitalized for acute heart failure with transient, persistent, or no WRF. METHODS: We identified patients 65 years or older hospitalized with acute heart failure from a clinical registry linked to Medicare claims data. We defined WRF as an increase in serum creatinine of ≥ 0.3 mg/dL after admission. We further classified patients with WRF by the difference between admission and last recorded serum creatinine levels into transient WRF (< 0.3 mg/dL) or persistent WRF (≥ 0.3 mg/dL). We examined unadjusted rates and adjusted associations between 90-day outcomes and WRF status. RESULTS: Among 27,309 patients, 18,568 (68.0%) had no WRF, 3,205 (11.7%) had transient WRF, and 5,536 (20.3%) had persistent WRF. Patients with WRF had higher observed rates of 90-day postdischarge all-cause readmission and 90-day postadmission mortality (P < .001). After multivariable adjustment, transient WRF (hazard ratio [HR] 1.19, 99% CI 1.05-1.35) and persistent WRF (HR 1.73, 99% CI 1.57-1.91) were associated with higher risks of 90-day postadmission mortality (P < .001 for both). Compared with transient WRF, persistent WRF was associated with a higher risk of 90-day postadmission mortality (HR 1.46, 99% CI 1.28-1.66, P < .001). CONCLUSIONS: Transient and persistent WRF during hospitalization for acute heart failure were associated with higher adjusted risks for 90-day all-cause postadmission mortality. Patients with persistent WRF had worse outcomes.


Subject(s)
Creatinine/blood , Heart Failure , Renal Insufficiency , Acute Disease , Aged , Disease Progression , Female , Heart Failure/blood , Heart Failure/complications , Heart Failure/epidemiology , Heart Failure/physiopathology , Heart Failure/therapy , Hospitalization/statistics & numerical data , Humans , Kidney Function Tests/methods , Kidney Function Tests/statistics & numerical data , Male , Outcome Assessment, Health Care , Prognosis , Proportional Hazards Models , Renal Insufficiency/blood , Renal Insufficiency/diagnosis , Renal Insufficiency/epidemiology , Renal Insufficiency/etiology , Renal Insufficiency/physiopathology , Renal Insufficiency/prevention & control , Risk Assessment , Survival Analysis , United States/epidemiology
18.
Curr Opin Crit Care ; 20(5): 478-83, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25111680

ABSTRACT

PURPOSE OF REVIEW: Fluid removal and relief of congestion are central to treatment of acute heart failure. Diuretics have been the decongestive mainstay but their known limitations have led to the exploration of alternative strategies. This review compares diuretics with ultrafiltration and examines the recent evidence evaluating their use. RECENT FINDINGS: Relevant recent studies are the Diuretic Optimization Strategies Evaluation trial (of diuretics) and the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (of ultrafiltration). The Diuretic Optimization Strategies Evaluation study evaluated strategies of loop diuretic use during acute heart failure (continuous infusion versus intermittent bolus and high dose versus low dose). After 72  h, there was no significant difference with either comparison for the coprimary end points. Patients treated with a high-dose strategy tended to have greater diuresis and more decongestion compared with low-dose therapy, at the cost of transient changes in renal function. The Cardiorenal Rescue Study in Acute Decompensated Heart Failure study showed that in acute heart failure patients with persistent congestion and worsening renal function, ultrafiltration, as compared with a medical therapy, was associated with similar weight loss but greater increase in serum creatinine and more adverse events. SUMMARY: Decongestion remains a major challenge in acute heart failure. Although recent studies provide useful data to guide practice, the relatively poor outcomes point to the continued need to identify better strategies for safe and effective decongestion.


Subject(s)
Diuretics/administration & dosage , Heart Failure/therapy , Ultrafiltration/methods , Acute Disease , Creatinine/blood , Diuretics/adverse effects , Heart Failure/complications , Heart Failure/physiopathology , Humans , Infusions, Intravenous , Practice Guidelines as Topic , Treatment Outcome , Ultrafiltration/adverse effects , Weight Loss
19.
J Heart Lung Transplant ; 33(9): 937-42, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24997496

ABSTRACT

BACKGROUND: Aortic insufficiency (AI) in patients supported with continuous-flow left ventricular assist devices (CF-LVAD) results in regurgitant volume returning from the aorta to the left ventricle, increased LVAD pump volume and reduced systemic cardiac output. One common strategy to address AI during CF-LVAD support is central oversewing of the aortic valve, which allows some opening between the valve leaflets laterally. However, the long-term durability of this technique has not been extensively described. METHODS: All patients who underwent central oversewing of the aortic valve during CF-LVAD support between January 2006 and March 2013 were included in this analysis. Pre- and post-procedure intra-operative transesophageal echocardiograms (TEEs) were reviewed to determine the efficacy of the surgical technique, whereas all subsequent transthoracic echocardiograms (TTEs) were reviewed to assess durability. AI severity was graded using the vena contracta (VC) width and the ratio between the VC and left ventricular outflow tract (LVOT) diameter. RESULTS: Nineteen patients with central aortic valve oversewing were identified. Median follow-up was 560 days (range 46 to 954 days). All but 1 patient had their aortic insufficiency reduced to "none/trace" on post-operative TEE. There was no statistically significant increase in the VC width and VC/LVOT ratio between the first and last follow-up echocardiograms, and only 2 patients developed more than mild aortic insufficiency after central oversewing. Central oversewing of the aortic valve did not adversely affect outcomes after LVAD implantation. CONCLUSION: Central oversewing of the aortic valve is an effective and durable means of addressing greater than mild AI in patients with CF-LVAD.


Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Heart-Assist Devices , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/physiopathology , Cardiac Output/physiology , Echocardiography , Follow-Up Studies , Heart Failure/therapy , Humans , Retrospective Studies , Severity of Illness Index , Treatment Outcome
20.
J Cardiovasc Electrophysiol ; 25(11): 1199-205, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24890850

ABSTRACT

INTRODUCTION: Heart failure patients with left ventricular assist devices (LVADs) are at risk for infection. Cardiac implantable electronic devices (CIEDs) are commonly present in these patients. The course of infections in patients with an LVAD and a CIED is not well described. METHODS AND RESULTS: We identified 6 patients with a durable LVAD that underwent CIED removal because of an LVAD associated infection (LVADI). Patient and infection characteristics, management strategy, and clinical outcomes are described. All 6 patients were male, and the mean age was 59.6 years (range 43-72). Four of 6 patients had an ischemic cardiomyopathy, and 3 patients were diabetic. The median creatinine clearance for patients was 40.5 mg/dL (range 19-65). Five of 6 patients had a continuous flow LVAD placed as destination therapy. Four of 6 patients had a previous LVADI managed medically before the current infection leading to CIED removal. The indication for CIED removal was a bloodstream infection in 5 of 6 patients. Three of these patients had potential vegetations identified by echocardiography on device leads. The mean implanted age of the removed leads was 62 months (range 1-179), and 1 of the 6 patients experienced a procedural complication (hematoma) from CIED removal. Four of 6 patients that underwent CIED removal for an LVADI had recurrence of infection. Five of 6 patients died during the initial presentation or from repeat presentation for infection. CONCLUSION: Despite CIED removal for an LVADI, recurrent infections are common and mortality remains high.


Subject(s)
Defibrillators, Implantable/microbiology , Device Removal/methods , Heart-Assist Devices/microbiology , Prosthesis-Related Infections/surgery , Adult , Aged , Cohort Studies , Defibrillators, Implantable/adverse effects , Female , Heart Ventricles/microbiology , Heart Ventricles/surgery , Heart-Assist Devices/adverse effects , Humans , Male , Middle Aged , Prosthesis-Related Infections/diagnosis , Retrospective Studies , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL
...