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Greene S.J.,Northwestern University | Gheorghiade M.,Northwestern University | Vaduganathan M.,Harvard University | Ambrosy A.P.,Stanford University | And 7 more authors.
European Journal of Heart Failure | Year: 2013

Aims Haemoconcentration has been studied as a marker of decongestion in patients with hospitalization for heart failure (HHF).We describe the relationship between haemoconcentration, worsening renal function, post-discharge outcomes, and clinical and laboratory markers of congestion in a large multinational cohort of patients with HHF. Methods and results In 1684 patients with HHF with ejection fraction (EF) ≤40% assigned to the placebo arm of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial, absolute in-hospital haematocrit change was calculated as the change between baseline and discharge or day 7 (whichever occurred first). Patient characteristics, changes in renal function, and outcomes over a median follow-up of 9.9 months were compared by in-hospital haematocrit change. Overall, 26% of patients had evidence of haemoconcentration (i.e. ≥3% absolute increase in haematocrit). Patients with greater increases in haematocrit tended to have better baseline renal function. Haemoconcentration correlated with greater risk of in-hospital worsening renal function, but renal parameters generally returned to baseline within 4weeks post-discharge. Patients with haemoconcentrationwere less likely to have clinical congestion at discharge, and experienced greater in-hospital decreases in body weight and natriuretic peptide levels. After adjustment for baseline clinical risk factors, every 5% increase of in-hospital haematocrit changewas associated with a decreased risk of all-cause death [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.70-0.95]. Haematocrit change was also associated with decreased cardiovascular mortality or heart failure (HF) hospitalization at ≤100 days post-randomization (HR 0.73, 95% CI 0.71-0.76). Conclusion In this large cohort of patients with HHF with reduced EF, haemoconcentration was associated with greater improvements in congestion and decreased mortality and HF re-hospitalization despite an increased risk of in-hospital worsening renal function. © The Author 2013. Source

van Nunen L.X.,Catharina Hospital Eindhoven | Noc M.,University of Ljubljana | Kapur N.K.,The Cardiovascular Center | Patel M.R.,Duke University | And 2 more authors.
American Journal of Cardiology | Year: 2016

Intra-aortic balloon pump (IABP) counterpulsation is the most widely used mechanical circulatory support device because of its ease of use, low complication rate, and fast manner of insertion. Its benefit is still subject of debate, and a considerable gap exists between guidelines and clinical practice. Retrospective nonrandomized studies and animal experiments show benefits of IABP therapy. However, recent large randomized trials do not show benefit of IABP therapy, which has led to a downgrading in the guidelines. In our view, this dichotomy between trials and practice might be the result of insufficient understanding of the prerequisites needed for effective IABP therapy, that is, exhausted autoregulation, and of not including the right patient population in trials. The population included in recent large randomized trials has been heterogeneous, also including patients in whom benefit of IABP could not be expected. The clinical condition in which most benefit is expected, that is persistent ischemia in acute ST-elevation myocardial infarction, is discussed in this review. In conclusion, this review aims to explain the physiological principles needed for effective IABP therapy, to reflect critically on the large randomized trials, and to solve some of the controversies in this field. © 2016 Elsevier Inc. Source

Benoit E.,Tufts Medical Center | O'Donnell Jr. T.F.,The Cardiovascular Center | Patel A.N.,University of Utah
Cell Transplantation | Year: 2013

Researchers have accumulated a decade of experience with autologous cell therapy in the treatment of critical limb ischemia (CLI). We conducted a systematic review of clinical trials in the literature to determine the safety and efficacy of cell therapy in CLI. We searched the literature for clinical trials of autologous cell therapy in CLI, including observational series of five or more patients to accrue a large pool of patients for safety analysis. Safety analysis included evaluation of death, cancer, unregulated angiogenesis, and procedural adverse events such as bleeding. Efficacy analysis included the clinical endpoints amputation and death as well as functional and surrogate endpoints. We identified 45 clinical trials, including seven RCTs, and 1,272 patients who received cell therapy. The overall adverse event rate was low (4.2%). Cell therapy patients did not have a higher mortality rate than control patients and demonstrated no increase in cancer incidence when analyzed against population rates. With regard to efficacy, cell therapy patients had a significantly lower amputation rate than control patients (OR 0.36, p = 0.0004). Cell therapy also demonstrated efficacy in a variety of functional and surrogate outcomes. Clinical trials differed in the proportion of patients with risk factors for clinical outcomes, and these influenced rates of amputation and death. Cell therapy presents a favorable safety profile with a low adverse event rate and no increase in severe events such as mortality and cancer and treatment with cell therapy decreases the risk of amputation. Cell therapy has a positive benefit-to-risk ratio in CLI and may be a valuable treatment option, particularly for those challenging patients who cannot undergo arterial reconstruction. © 2013 Cognizant Comm. Corp. Source

Benoit E.,The Cardiovascular Center | O'Donnell Jr T.F.,The Cardiovascular Center | Iafrati M.D.,The Cardiovascular Center | Asher E.,Maimonides Medical Center | And 7 more authors.
Journal of Translational Medicine | Year: 2011

Background: Autologous bone marrow-derived stem cells have been ascribed an important therapeutic role in No-Option Critical limb Ischemia (NO-CLI). One primary endpoint for evaluating NO-CLI therapy is major amputation (AMP), which is usually combined with mortality for AMP-free survival (AFS). Only a trial which is double blinded can eliminate physician and patient bias as to the timing and reason for AMP. We examined factors influencing AMP in a prospective double-blinded pilot RCT (2:1 therapy to control) of 48 patients treated with site of service obtained bone marrow cells (BMAC) as well as a systematic review of the literature.Methods: Cells were injected intramuscularly in the CLI limbs as either BMAC or placebo (peripheral blood). Six month AMP rates were compared between the two arms. Both patient and treating team were blinded of the assignment in follow-up examinations. A search of the literature identified 9 NO-CLI trials, the control arms of which were used to determine 6 month AMP rates and the influence of tissue loss.Results: Fifteen amputations occurred during the 6 month period, 86.7% of these during the first 4 months. One amputation occurred in a Rutherford 4 patient. The difference in amputation rate between patients with rest pain (5.6%) and those with tissue loss (46.7%), irrespective of treatment group, was significant (p = 0.0029). In patients with tissue loss, treatment with BMAC demonstrated a lower amputation rate than placebo (39.1% vs. 71.4%, p = 0.1337). The Kaplan-Meier time to amputation was longer in the BMAC group than in the placebo group (p = 0.067). Projecting these results to a pivotal trial, a bootstrap simulation model showed significant difference in AFS between BMAC and placebo with a power of 95% for a sample size of 210 patients. Meta-analysis of the literature confirmed a difference in amputation rate between patients with tissue loss and rest pain.Conclusions: BMAC shows promise in improving AMP-free survival if the trends in this pilot study are validated in a larger pivotal trial. The difference in amp rate between Rutherford 4 & 5 patients suggests that these patients should be stratified in future RCTs. © 2011 Benoit et al; licensee BioMed Central Ltd. Source

Kapur N.K.,The Cardiovascular Center | Paruchuri V.,The Cardiovascular Center | Jagannathan A.,The Cardiovascular Center | Steinberg D.,Medical University of South Carolina | And 11 more authors.
JACC: Heart Failure | Year: 2013

Objectives: The aim of this study was to explore the clinical utility of a commercially available centrifugal flow pump as a centrifugal flow-right ventricular support device (CF-RVSD) in patients with right ventricular failure (RVF). Background: RVF is associated with high in-hospital mortality. Limited data regarding efficacy of the CF-RVSD for RVF exist. Methods: We retrospectively reviewed data from 46 patients receiving a CF-RVSD for RVF from a registry comprising data from 8 tertiary-care hospitals in the United States. CF-RVSD use was recorded in the setting of acute myocardial infarction; myocarditis; chronic left heart failure; after valve surgery, orthotopic heart transplantation, left ventricular assist device surgery, coronary bypass grafting. Devices were implanted via the percutaneous (n = 22) or surgical (n = 24) route. Results: No intraprocedural mortality was observed. Mean time from admission to CF-RVSD implantation was 5.7 ± 8.5 days, with a mean of 6,769 ± 789 rotations/min, providing 4.2 ± 1.3 l/min of flow. Mean duration of support was 5.4 ± 5.1 days. Mean arterial pressure (65 ± 12 mm Hg vs. 73 ± 14 mm Hg; p < 0.05), right atrial pressure (21 ± 8 mm Hg vs. 16 ± 7 mm Hg; p = 0.05), pulmonary artery systolic pressure (43 ± 15 mm Hg vs. 33 ± 15 mm Hg; p = 0.01), and cardiac index (1.7 ± 0.7 vs. 2.2 ± 0.6; p = 0.01) were improved within 48 h of CF-RVSD implantation. Total in-hospital mortality was 57% and was lowest in the setting of left ventricular assist device implantation, chronic left heart failure, and acute myocardial infarction. Increased age, biventricular failure, and Thrombolysis In Myocardial Infarction-defined major bleeding were associated with increased in-hospital mortality. Conclusions: Use of the CF-RVSD for RVF is clinically feasible and associated with improved hemodynamic status. Observations from the registry of patients who have received this device may support the development of prospective studies that will examine the role of percutaneous circulatory support for RVF. © 2013 American College of Cardiology Foundation. Source

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