ABSTRACT
BACKGROUND: The United States has recently undergone increases in the legalization and use of marijuana. There have been previous reports on the association of cannabis use and myocardial dysfunction, however, few on the association with acute stress cardiomyopathy and cardiogenic shock. CASE REPORT: This is a case of a 58-year-old female with a history of inhaled cannabis use, no history of diabetes, and no known history of cardiac disease, that illustrates an association between cannabis use and the recurrent development of stress cardiomyopathy and cardiogenic shock. A review of medical records was performed from two hospitalizations and subsequent outpatient follow-up for similar presentations 6 years apart and review of literature regarding cannabis use and its association with cardiac dysfunction. In separate hospitalizations, the patient presented with clinical findings of cardiogenic shock, severe left ventricular dysfunction with morphologic features of stress cardiomyopathy, and normal coronary angiography. Laboratory results included elevated cardiac biomarkers and urine tetrahydrocannabinol levels > 300 ng/mL. The patient required intensive cardiovascular support, but recovered with normal cardiac function after each event. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: As use of cannabis becomes more prevalent, it will be important for physicians to recognize the potential association of cannabis use and acute myocardial dysfunction, and how early treatment may contribute to salutary outcomes.
Subject(s)
Cannabis/adverse effects , Marijuana Abuse/complications , Shock/etiology , Cardiomyopathies/diagnosis , Cardiomyopathies/etiology , Electrocardiography/methods , Female , Humans , Hypotension/etiology , Intra-Aortic Balloon Pumping/methods , Marijuana Abuse/physiopathology , Middle Aged , Recurrence , Shock/diagnosisABSTRACT
Importance: In-hospital ST-segment elevation myocardial infarction (STEMI) is a unique clinical entity with epidemiology, incidence, and outcomes distinct from that of out-of-hospital STEMI and has only within the past 10 years begun to receive increased attention and research. Patients with in-hospital STEMI are older, have more comorbidities, and more frequently have coagulopathies and contraindications for anticoagulation and fibrinolytic therapy. A standardized clinical definition of in-hospital STEMI is lacking. The objectives of this special communication are to (1) summarize the knowledge base regarding in-hospital STEMI; (2) review the challenges of diagnosis and treatment of patients with in-hospital STEMI; (3) present a standardized clinical definition for in-hospital STEMI; and (4) provide a quality improvement protocol to improve diagnosis, triage, and treatment of patients with in-hospital STEMI. Observations: Patients with in-hospital STEMI less frequently present with typical angina symptoms, and an electrocardiogram is often obtained owing to changes in clinical status, changes on telemetry, or a finding of elevated cardiac biomarker. The frequent nontypical presentations often lead to substantial delays in the diagnosis of STEMI. Only 34% to 71% of patients with in-hospital STEMI undergo diagnostic catheterization, and only 22% to 56% undergo percutaneous coronary intervention. Even in contemporary reports, some studies report in-hospital mortality in the range of 31% to 42%. Three areas of delay in the treatment of patients with in-hospital STEMI that merit particular attention are (1) delays in electrocardiogram acquisition, (2) delays in electrocardiogram interpretation, and (3) delays in activation of existing STEMI systems of care. Conclusions and Relevance: Treatment of patients with in-hospital STEMI is more complex and challenging than treatment of patients who develop out-of-hospital STEMI, leading to delays in diagnosis and triage and less frequent use of reperfusion therapy. Quality improvement programs targeted at decreasing delays and streamlining treatment of such patients may improve treatment and outcome.
Subject(s)
ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/therapy , Clinical Protocols , Hospitalization , Humans , Quality Improvement , TriageABSTRACT
More than 1 million heart failure hospitalizations occur annually, and congestion is the predominant cause. Rehospitalizations for recurrent congestion portend poor outcomes independently of age and renal function. Persistent congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No decongestive pharmacological therapy has reduced these harmful consequences. Simplified ultrafiltration devices permit fluid removal in lower-acuity hospital settings, but with conflicting results regarding safety and efficacy. Ultrafiltration performed at fixed rates after onset of therapy-induced increased serum creatinine was not superior to standard care and resulted in more complications. In contrast, compared with diuretic agents, some data suggest that adjustment of ultrafiltration rates to patients' vital signs and renal function may be associated with more effective decongestion and fewer heart failure events. Essential aspects of ultrafiltration remain poorly defined. Further research is urgently needed, given the burden of congestion and data suggesting sustained benefits of early and adjustable ultrafiltration.
Subject(s)
Heart Failure/therapy , Hemofiltration , Blood Volume , Diuretics/therapeutic use , Humans , Pilot Projects , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVES: Without early revascularization, both inpatient and outpatient STEMIs have poor outcomes. Reasons for denying PCI for STEMI, however, remain uncertain. This single-center retrospective cohort study compares factors and outcomes associated with ineligibility for PCI between inpatients and outpatients following ST-elevation myocardial infarction (STEMI). METHODS: A total of 1,759 STEMI patients between June 2009 and January 2015 were assessed. Individual medical records were reviewed to obtain reasons for PCI ineligibility for STEMI patients who did not receive reperfusion therapy. RESULTS: Compared to outpatients with STEMI (n = 1,688), inpatients (n = 71) were less likely to receive coronary angiography (60.6% vs 95.9%; P < 0.001) or PCI (50.7% vs 80.9%; P < 0.001), with longer ECG/door to first device activation times (97 [78, 131] vs 63 [49, 78] minutes; P < 0.001). When coronary angiography was performed, however, similar rates of PCI and procedural success were seen in both groups. Principal contraindication for PCI was risk of bleeding within the inpatient population and complex coronary artery disease within the outpatient population. Total in-hospital mortality was higher in inpatient STEMIs compared to outpatients (42.2% vs 10.0%; P < 0.001), but lower for patients eligible for PCI in both groups. CONCLUSIONS: Reasons for PCI ineligibility differ between inpatient and outpatient STEMIs. Inpatients have increased risks of bleeding, lower coronary angiography and PCI use, and higher in-hospital mortality. Especially for inpatients, specific PCI STEMI protocols that anticipate and overcome types of ineligibility and delay for cardiac catheterization may improve outcomes.
Subject(s)
Eligibility Determination , Inpatients/statistics & numerical data , Outpatients/statistics & numerical data , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Aged , Coronary Angiography/methods , Eligibility Determination/methods , Eligibility Determination/statistics & numerical data , Female , Hospital Mortality , Humans , Male , Middle Aged , North Carolina/epidemiology , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/statistics & numerical data , Retrospective Studies , Risk Assessment/methods , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/mortality , ST Elevation Myocardial Infarction/physiopathology , ST Elevation Myocardial Infarction/therapy , Time Factors , Treatment OutcomeABSTRACT
Timely reperfusion therapy reduces complications and improves survival in ST elevation myocardial infarction (STEMI). An effective chain of survival has been established for STEMIs occur in the community (outpatient STEMI). Recent studies have identified a subgroup of patients who develop STEMI while hospitalized for primary conditions, often not directly related to coronary artery disease (in-hospital STEMI or inpatient STEMI). This article summarizes current understanding of patient demographics, clinical characteristics, care delivery system and outcomes of in-hospital STEMI, comparing with outpatient STEMI. We also identified opportunities for quality improvement and proposed strategies and future directions to improve care for these patients.
Subject(s)
Inpatients , Outpatients , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction/therapy , Hospitalization , Humans , Treatment OutcomeABSTRACT
OBJECTIVES: The AVOID-HF (Aquapheresis versus Intravenous Diuretics and Hospitalization for Heart Failure) trial tested the hypothesis that patients hospitalized for HF treated with adjustable ultrafiltration (AUF) would have a longer time to first HF event within 90 days after hospital discharge than those receiving adjustable intravenous loop diuretics (ALD). BACKGROUND: Congestion in hospitalized heart failure (HF) patients portends unfavorable outcomes. METHODS: The AVOID-HF trial, designed as a multicenter, 1-to-1 randomized study of 810 hospitalized HF patients, was terminated unilaterally and prematurely by the sponsor (Baxter Healthcare, Deerfield, Illinois) after enrollment of 224 patients (27.5%). Aquadex FlexFlow System (Baxter Healthcare) was used for AUF. A Clinical Events Committee, blinded to the randomized treatment, adjudicated whether 90-day events were due to HF. RESULTS: A total of 110 patients were randomized to AUF and 114 to ALD. Baseline characteristics were similar. Estimated days to first HF event for the AUF and ALD group were, respectively, 62 and 34 (p = 0.106). At 30 days, compared with the ALD group, the AUF group had fewer HF and cardiovascular events. Renal function changes were similar. More AUF patients experienced an adverse effect of special interest (p = 0.018) and a serious study product-related adverse event (p = 0.026). The 90-day mortality was similar. CONCLUSIONS: Compared with the ALD group, the AUF group trended toward a longer time to first HF event within 90 days and fewer HF and cardiovascular events. More patients in the AUF group experienced special interest or serious product-related adverse event. Due to the trial's untimely termination, additional AUF investigation is warranted.
Subject(s)
Heart Failure/therapy , Hospitalization/trends , Sodium Potassium Chloride Symporter Inhibitors/administration & dosage , Ultrafiltration/methods , Aged , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Heart Failure/physiopathology , Humans , Infusions, Intravenous , Male , Prospective Studies , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: In patients hospitalized with acutely decompensated heart failure, unresolved signs and symptoms of fluid overload have been consistently associated with poor outcomes. Regardless of dosing and type of administration, intravenous loop diuretics have not reduced heart failure events or mortality in patients with acutely decompensated heart failure. The results of trials comparing intravenous loop diuretics to mechanical fluid removal by isolated venovenous ultrafiltration have yielded conflicting results. Studies evaluating early decongestive strategies have shown that ultrafiltration removed more fluid and was associated with fewer heart failure-related rehospitalization than intravenous loop diuretics. In contrast, when used in the setting of worsening renal function, ultrafiltration was associated with poorer renal outcomes and no reduction in heart failure events. METHODS: The AVOID-HF trial seeks to determine if an early strategy of ultrafiltration in patients with acutely decompensated heart failure is associated with fewer heart failure events at 90 days compared with a strategy based on intravenous loop diuretics. Study subjects from 40 highly experienced institutions are randomized to either early ultrafiltration or intravenous loop diuretics. In both treatment arms, fluid removal therapies are adjusted according to the patients' hemodynamic condition and renal function. The study was unilaterally terminated by the sponsor in the absence of futility and safety concerns after the enrollment of 221 subjects, or 27% of the originally planned sample size of 810 patients. CONCLUSIONS: The AVOID-HF trial's principal aim is to compare the safety and efficacy of ultrafiltration vs that of intravenous loop diuretics in patients hospitalized with acutely decompensated heart failure. Because stepped treatment approaches are applied in both ultrafiltration and intravenous loop diuretics groups and the primary end point is time to first heart failure event within 90 days, it is hoped that the AVOID-HF trial, despite its untimely termination by the sponsor, will provide further insight on how to optimally decongest patients with fluid-overloaded heart failure.
Subject(s)
Diuretics/administration & dosage , Heart Failure/therapy , Hospitalization/statistics & numerical data , Ultrafiltration/methods , Aged , Dose-Response Relationship, Drug , Female , Follow-Up Studies , Heart Failure/physiopathology , Humans , Infusions, Intravenous , Male , Prospective Studies , Time Factors , Treatment OutcomeABSTRACT
CONTEXT: Extracorporeal cardiopulmonary resuscitation (ECPR) refers to emergent percutaneous veno-arterial cardiopulmonary bypass to stabilize and provide temporary support of patients who suffer cardiopulmonary arrest. Initiation of ECPR by emergency physicians with meaningful long-term patient survival has not been demonstrated. OBJECTIVE: To determine whether emergency physicians could successfully incorporate ECPR into the resuscitation of patients who present to the emergency department (ED) with cardiopulmonary collapse refractory to traditional resuscitative efforts. DESIGN: A three-stage algorithm was developed for ED ECPR in patients meeting inclusion/exclusion criteria. We report a case series describing our experience with this algorithm over a 1-year period. RESULTS: 42 patients presented to our ED with cardiopulmonary collapse over the 1-year study period. Of these, 18 patients met inclusion/exclusion criteria for the algorithm. 8 patients were admitted to the hospital after successful ED ECPR and 5 of those patients survived to hospital discharge neurologically intact. 10 patients were not started on bypass support because either their clinical conditions improved or resuscitative efforts were terminated. CONCLUSION: Emergency physicians can successfully incorporate ED ECPR in the resuscitation of patients who suffer acute cardiopulmonary collapse. More studies are necessary to determine the true efficacy of this therapy.
Subject(s)
Algorithms , Cardiopulmonary Bypass , Cardiopulmonary Resuscitation/methods , Emergency Medicine , Heart Arrest/therapy , Aged , Emergency Service, Hospital , Female , Heart Arrest/mortality , Humans , Male , Middle Aged , Observation , Patient Discharge , Retrospective StudiesABSTRACT
BACKGROUND: The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) improved survival in destination therapy (DT) patients during a randomized trial compared with pulsatile-flow LVADs. This study documented changes in cognitive performance in DT patients from that trial to determine if there were differences between continuous-flow and pulsatile-flow support. METHODS: Data were collected in a sub-study from 96 HeartMate II continuous-flow and 30 HeartMate XVE pulsatile-flow LVAD patients from 12 of the 35 trial sites that followed the same serial neurocognitive (NC) testing protocol at 1, 3, 6, 12, and 24 months after LVAD implantation. Spatial perception, memory, language, executive functions, and processing speed were the domains assessed with 10 standard cognitive measures. Differences over time and between LVAD type were evaluated with linear mixed-effects modeling. RESULTS: From 1 to 24 months after LVAD implantation, changes in NC functions were stable or showed improvement in all domains, and there were no differences between the continuous-flow and pulsatile-flow groups. Data at 24 months were only available from patients with the continuous-flow LVAD due to the limited durability of the HeartMate XVE device. There was no decline in any NC domain over the time of LVAD support. Missing data not collected from patients who died could have resulted in a bias toward inflated study results. CONCLUSIONS: The NC performance of advanced heart failure patients supported with continuous-flow and pulsatile-flow LVADs shows stabilization or improvement during support for up to 24 months.
Subject(s)
Cognition/physiology , Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices , Adult , Aged , Female , Follow-Up Studies , Heart Failure/physiopathology , Heart Failure/psychology , Humans , Male , Memory/physiology , Middle Aged , Prosthesis Design , Treatment OutcomeSubject(s)
Advisory Committees , Cardiology/methods , Cardiology/standards , Cardiovascular Diseases/therapy , Clinical Competence , Disease Management , Heart Failure/therapy , Heart Transplantation/methods , Adolescent , Cardiology/education , Child , Curriculum , Female , Heart Transplantation/standards , Heart Transplantation/trends , Humans , Male , Societies, Medical , United StatesSubject(s)
Advisory Committees/standards , American Heart Association , Clinical Competence/standards , Heart Failure/surgery , Heart Transplantation/standards , Societies, Medical/standards , Advisory Committees/trends , Disease Management , Heart Failure/diagnosis , Heart Failure/therapy , Heart Transplantation/trends , Humans , Internship and Residency/standards , Internship and Residency/trends , Societies, Medical/trends , United StatesABSTRACT
OBJECTIVE: In-hospital cardiac arrest or refractory shock carries a high mortality despite the use of advanced resuscitative measures. We have implemented an in-hospital, nurse-based, continuously available, percutaneous, venoarterial cardiopulmonary bypass system, also known as extracorporeal life support (ECLS), as an adjunct to resuscitation when initial measures are ineffective. METHODS: In 1986, a system for the rapid initiation of ECLS, was created in which trained critical care nurses primed an ECLS circuit and in-house physicians percutaneously placed required cannulas. From a prospective registry, we assessed long-term survival (LTS) (> or =30 days, cardiopulmonary support weaned), short-term survival (<30 days, CPS weaned), or death on CPS. RESULTS: One hundred fifty patients (age, 57 +/- 17 years) were urgently started on CPS for cardiac arrest (n = 127; witnessed, n = 124; unwitnessed, n = 3) and refractory shock (n = 23). Sixty-nine patients were weaned from CPS, and 81 could not be weaned. Overall, 39 (26.0%) patients achieved LTS with a subsequent Kaplan-Meier median survival of 9.5 years. Duration of CPS was 32 +/- 38 hours for LTS and 21 +/- 38 hours for non-LTS. LTS occurred in 29 (23.4%) of 124 patients started on CPS for witnessed cardiac arrest and 11 (47.8%) of 23 for refractory shock (P < .05). Among patients with CPS initiated in the cardiac catheterization laboratory, LTS was seen in 24 (50.0%) of 48 versus 15 (14.7%) of 102 in patients with CPS initiated in other locations (P < .001). Cardiopulmonary resuscitation times greater than or equal to 30 minutes were associated with lower LTS (P < .05). The most common cause of death during CPS was refractory cardiac dysfunction (39.5%), and the most common cause associated with short-term survival was neurologic/pulmonary dysfunction (53.6%). Seven patients were bridged to a left ventricular assist device, and 1 subsequently underwent heart transplantation. Multivariate analysis revealed only cardiac catheterization laboratory site of initiation as a significant independent predictor of LTS (P < .01). When dividing the 20-year experience in tertiles, recent recipients have had more common prearrest insertion. Rates of long-term survival have not changed. CONCLUSION: Of patients started on CPS, 46% were weaned, and 26.0% were long-time survivors. Rapid initiation of CPS permits LTS for some inpatients with cardiovascular collapse when initial advanced resuscitation fails. Strategies to improve end-organ function associated with use of CPS should lead to greater LTS. This practical application of inexpensive available technology should be more widely used.
Subject(s)
Cardiopulmonary Bypass , Emergency Treatment , Heart Arrest/surgery , Cardiopulmonary Bypass/methods , Female , Heart Arrest/mortality , Humans , Male , Middle Aged , Prospective Studies , Survival Rate , Survivors , Time FactorsABSTRACT
BACKGROUND: SERCA2a deficiency is commonly seen in advanced heart failure (HF). This study is designed to investigate safety and biological effects of enzyme replacement using gene transfer in patients with advanced HF. METHODS AND RESULTS: A total of 9 patients with advanced HF (New York Heart Association [NYHA] Class III/IV, ejection fraction [EF] < or = 30%, maximal oxygen uptake [VO2 max] <16 mL.kg.min, with maximal pharmacological and device therapy) received a single intracoronary infusion of AAV1/SERCA2a in the open-label portion of this ongoing study. Doses administered ranged from 1.4 x 10(11) to 3 x 10(12) DNase resistant particles per patient. We present 6- to 12-month follow-up data for these patients. AAV1/SERCA2a demonstrated an acceptable safety profile in this advanced HF population. Of the 9 patients treated, several demonstrated improvements from baseline to month 6 across a number of parameters important in HF, including symptomatic (NYHA and Minnesota Living with Heart Failure Questionnaire, 5 patients), functional (6-minute walk test and VO2 max, 4 patients), biomarker (NT-ProBNP, 2 patients), and LV function/remodeling (EF and end-systolic volume, 5 patients). Of note, 2 patients who failed to improve had preexisting anti-AAV1 neutralizing antibodies. CONCLUSIONS: Quantitative evidence of biological activity across a number of parameters important for assessing HF status could be detected in several patients without preexisting neutralizing antibodies in this open-label study, although the number of patients in each cohort is too small to conduct statistical analyses. These findings support the initiation of the Phase 2 double-blind, placebo-controlled portion of this study.
Subject(s)
Genetic Therapy , Heart Failure/therapy , Sarcoplasmic Reticulum Calcium-Transporting ATPases/genetics , Exercise Test , Female , Heart Failure/genetics , Humans , Infusions, Intra-Arterial , Male , Middle Aged , Natriuretic Peptide, Brain/blood , Oxygen Consumption , Peptide Fragments/blood , Sarcoplasmic Reticulum Calcium-Transporting ATPases/administration & dosage , Stroke Volume , Systole , Up-Regulation , Ventricular RemodelingABSTRACT
BACKGROUND: Ultrafiltration (UF) can rapidly and predictably remove extracellular and intravascular fluid volume. To date, assessment of UF in patients with cardiovascular disease has been confined to short- and medium-term studies in patients with a principal diagnosis of acute heart failure. METHODS: In-hospital and long-term outcomes were reviewed from consecutive patients with cardiovascular disorders and recognized pulmonary and systemic volume overload treated with a simplified UF system with the capability for peripheral venovenous access. Trained abstractors reviewed both paper and electronic medical records. Patients with a principal diagnosis of heart failure versus other primary hospital discharge diagnoses were identified according to International Classification of Diseases, 9th Revision standards by independent coders. RESULTS: For a period of 43 months, 100 patients (76 male/24 female, 65 +/- 14.0 years of age, systolic dysfunction 64%) were treated with UF during 130 hospitalizations. Baseline systolic blood pressure was 119 +/- 23 mm Hg. Before UF, 53% were receiving intravenous vasoactive therapy. By using UF, 7.1 +/- 3.9 L of ultrafiltrate were removed during 2.0 +/- 1.2 treatments per hospitalization. Baseline creatinine was 1.8 +/- 0.8 and 1.9 +/- 1.2 (not significant) at discharge. Of the 15 in-hospital deaths, 14 occurred during the initial hospitalization. Left ventricular dysfunction was related to 13 (87%) of the 15 deaths; no deaths were related to UF use. In hospitalizations with a principal diagnosis of heart failure (n = 79), in-hospital mortality was 7.6% compared with an ADHERE risk tree estimated mortality of 7.5%. Multivariate logistic regression identified a trend for decreased systolic blood pressure to predict patient initial hospitalization mortality (P = .06). Kaplan-Meier survivals for all patients were 71% at 1 year and 67% at 2 years. Cox regression found decreased systolic blood pressure as a predictor of long-term mortality (P = .025). Total volume of ultrafiltrate removed, ejection fraction, history of coronary artery disease, creatinine clearance, gender, age, and principal diagnosis of heart failure were not significantly associated with long-term mortality. CONCLUSION: This series extends the spectrum of patients previously reported to be treated with UF. Despite marked volume overload, UF-treated patients with a principal diagnosis of heart failure had inpatient outcomes similar to the ADHERE registry. UF should be considered for a broad range of patients who present with volume overload.
Subject(s)
Cardiovascular Diseases/mortality , Cardiovascular Diseases/therapy , Hemofiltration/trends , Aged , Cardiovascular Diseases/physiopathology , Female , Heart Failure/mortality , Heart Failure/physiopathology , Heart Failure/therapy , Hemofiltration/methods , Hospital Mortality/trends , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome , Ultrafiltration/methods , Ultrafiltration/trendsABSTRACT
INTRODUCTION: Mortality events in studies of cardiovascular disease are currently adjudicated using different methodologies depending on the investigators' preferences. Traditionally, deaths have been categorized by a single term, such as sudden, ischemic, or pump failure, a method that can be referred to as "categorical". In contrast, deaths may be categorized using several specific pieces of information about the event, a method that can be referred to as "multiparameter descriptive." Herein, we describe an adaptation of this descriptive method in a trial of patients with heart failure and arrhythmias. METHODS AND RESULTS: Case examples were selected from two clinical trials of an investigational implantable cardioverter-defibrillator (ICD)-biventricular pacing system in patients with symptomatic heart failure and a class I indication for ICD implantation, and the complete results for one of the trials are given. Deaths were classified according to the new descriptive method, and also according to published categorical methods for heart failure and arrhythmia trials. The descriptive method preserved traditional arrhythmia and heart failure trial single category classifications of death. Furthermore, there was agreement between the arrhythmia and heart failure category classifications in 126 of the 148 of the mortality events adjudicated (85%). CONCLUSION: A descriptive method for the classification of death retains more data and allows for comparison among trials using different classification schemes. This may allow greater mechanistic insight into study populations that have diverse and frequently multiple etiologies of death.
Subject(s)
Arrhythmias, Cardiac/mortality , Clinical Trials as Topic , Defibrillators, Implantable , Heart Failure/mortality , Arrhythmias, Cardiac/therapy , Cause of Death , Classification/methods , Death, Sudden, Cardiac/etiology , Heart Failure/therapy , Humans , Risk FactorsABSTRACT
OBJECTIVES: This study was designed to compare the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients. BACKGROUND: Early ultrafiltration may be an alternative to intravenous diuretics in patients with decompensated HF and volume overload. METHODS: Patients hospitalized for HF with > or =2 signs of hypervolemia were randomized to ultrafiltration or intravenous diuretics. Primary end points were weight loss and dyspnea assessment at 48 h after randomization. Secondary end points included net fluid loss at 48 h, functional capacity, HF rehospitalizations, and unscheduled visits in 90 days. Safety end points included changes in renal function, electrolytes, and blood pressure. RESULTS: Two hundred patients (63 +/- 15 years, 69% men, 71% ejection fraction < or =40%) were randomized to ultrafiltration or intravenous diuretics. At 48 h, weight (5.0 +/- 3.1 kg vs. 3.1 +/- 3.5 kg; p = 0.001) and net fluid loss (4.6 vs. 3.3 l; p = 0.001) were greater in the ultrafiltration group. Dyspnea scores were similar. At 90 days, the ultrafiltration group had fewer patients rehospitalized for HF (16 of 89 [18%] vs. 28 of 87 [32%]; p = 0.037), HF rehospitalizations (0.22 +/- 0.54 vs. 0.46 +/- 0.76; p = 0.022), rehospitalization days (1.4 +/- 4.2 vs. 3.8 +/- 8.5; p = 0.022) per patient, and unscheduled visits (14 of 65 [21%] vs. 29 of 66 [44%]; p = 0.009). No serum creatinine differences occurred between groups. Nine deaths occurred in the ultrafiltration group and 11 in the diuretics group. CONCLUSIONS: In decompensated HF, ultrafiltration safely produces greater weight and fluid loss than intravenous diuretics, reduces 90-day resource utilization for HF, and is an effective alternative therapy. (The UNLOAD trial; http://clinicaltrials.gov/ct/show/NCT00124137?order=1; NCT00124137).
Subject(s)
Diuretics/administration & dosage , Heart Failure/therapy , Hemofiltration , Ultrafiltration , Humans , Infusions, Intravenous , Male , Middle Aged , Treatment OutcomeSubject(s)
Intra-Aortic Balloon Pumping/methods , Myocarditis/physiopathology , Myocarditis/therapy , Adult , Blood Circulation/physiology , Cardiac Catheterization/methods , Electrocardiography , Enterovirus B, Human/pathogenicity , Enterovirus Infections/complications , Heart/physiopathology , Heart/virology , Humans , Intra-Aortic Balloon Pumping/instrumentation , Leg/blood supply , Male , Myocarditis/etiology , Ventricular Function, LeftABSTRACT
BACKGROUND: Patients with advanced heart failure may require long-term support with an intracorporeal left ventricular assist device (LVAD) before cardiac transplant, while awaiting myocardial recovery, or during destination therapy. Compared with the diagnosis of native heart dysfunction, there is less experience with the assessment of recurrent heart failure after LVAD placement. METHODS: Ten patients (9 men, 1 woman; age, 58 +/- 11 years) were studied after LVAD placement. Six patients were studied because of recurrent heart failure; the remaining 4 had other indications for study and are reported here as controls. Cardiac catheterization, including LVAD and cannulae catheterization, and angiography were performed. RESULTS: Inflow cannula valve regurgitation by LVAD angiography was found in 3 cases. Patients with regurgitation had a mean increased resting LVAD rate of 105 beats/min (range, 90-120); LVAD output exceeded forward cardiac output (LVAD - thermodilution cardiac output = +3.7 liters/min [0.6-6.4]). Inflow cannula obstruction identified with a filling phase pressure gradient between the left ventricle and the LVAD was found in 3 additional patients. Patients with obstruction had decreased resting LVAD rates (50 beats/min, all patients); LVAD output was less than the forward cardiac output (LVAD - thermodilution cardiac output = -2.3 liters/min [-0.8 to -3.5]). Compared with those with inflow valve regurgitation, patients with cannula obstruction had higher pulmonary capillary wedge pressures; phasic left ventricular pressure variation was reduced. Patients with cannula dysfunction underwent surgical intervention, and 4 of 6 were long-term survivors. CONCLUSIONS: When heart failure recurs after LVAD placement, abnormalities of the inflow cannula are common. Cardiac catheterization can confirm the diagnosis before surgical intervention. Hemodynamic coupling between the left ventricle and the LVAD is increased with inflow valve regurgitation and reduced with cannula obstruction.
Subject(s)
Equipment Failure , Heart Failure/pathology , Heart Failure/therapy , Heart-Assist Devices , Aged , Cardiac Catheterization , Cardiac Output , Case-Control Studies , Coronary Angiography , Female , Humans , Male , Middle Aged , Recurrence , Ventricular Dysfunction, Left/therapyABSTRACT
Fluid congestion is the hallmark of decompensated heart failure. As heart failure progresses, reduced response to diuretics is common. In these patients, ultrafiltration has been found to alleviate excess volume and improve diuretic sensitivity. Compared with diuretics, ultrafiltration provides a more predictable and safer way to achieve euvolemia with minimal electrolyte abnormalities and neurohormonal activation. The emerging familiarity and ease of use of ultrafiltration suggests that in the future this will be an important therapy for the treatment of acute and chronic volume overload associated with decompensated heart failure.