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PubMed | Duke University, King's College London, The Cardiovascular Center, University of Ljubljana and Catharina Hospital Eindhoven
Type: Journal Article | Journal: The 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.

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.

PubMed | The Cardiovascular Center and Institute for Clinical Research and Health Policy Studies
Type: Journal Article | Journal: Journal of vascular surgery. Venous and lymphatic disorders | Year: 2016

Endovenous ablation (EVA) of the great saphenous vein (GSV), with radiofrequency (RFA) or laser ablation (EVLA), has largely replaced the standard ligation and stripping (L&S). Several randomized controlled trials (RCTs) have reported data on efficacy of the ablation with little focus on complications. We analyzed the current literature for short-term complications of EVA as compared with L&S.We searched MEDLINE, the Cochrane Central Trials Registry, and individual journals from January 2008 through January 8, 2013 for RCTs comparing RFA and/or EVLA and/or L&S to treat GSV incompetence. We excluded studies using foam sclerotherapy, re-do GSV surgery, or the addition of a high GSV ligation to an EVA procedure. We meta-analysized short-term (<1 year) complications using the Peto odds ratio to elucidate differences between RFA (using the VNUS ClosureFAST catheter; VNUS Medical Technologies, Inc, San Jose, Calif), EVLA, and L&S.Seventeen RCTs met inclusion criteria. There were 317 patients who underwent RFA with ClosureFAST, 1057 patients who had EVLA, and 975 who had L&S. Seventy percent were female with a mean age of 47.5 years. The majority had CEAP clinical class 2 or 3. There was an overall complication rate of 39.6% in the 2624 limbs analyzed over all procedures. There was no evidence of a difference in the rates of venous thromboembolism. There was a significantly higher rate of wound infection for L&S (2.3%; 95% confidence interval [CI], 1.3%-3.1%) vs EVLA (0.5%; 95% CI, 0.3%-1.3%; P=.006), but not between L&S and RFA (1.5%; 95% CI, 0.4%-3.0%; P= .094). The paresthesia rate was significantly lower with EVLA (3.8%; 95% CI, 2.4%-4.5%) as compared with RFA (5.2%; 95% CI, 3.1%-7.9%; P< .001) and L&S (7.4%; 95% CI, 5.3%-8.3%; P< .001). The rate of thrombophlebitis was significantly lower for L&S (3.0%; 95% CI, 2.9%-4.0%) as compared with RFA (5.5%; 95% CI, 3.0%-7.8%; P= .003) and EVLA (5.6%; 95% CI, 4.2%-7.0%; P= .003). There was no difference in the rate of thermal skin burns between RFA and EVLA.Endovenous ablation and ligation and stripping of the GSV are not without complications, although usually minor. L&S has a higher wound infection rate and a lower thrombophlebitis rate as compared with EVA. EVLA has a significantly lower rate of paresthesia as compared with RFAand L&S. Thermal skin burns occur with equal frequency in RFA and EVLA.

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.

PubMed | University of Porto, University of Lorraine and The CardioVascular Center
Type: Journal Article | Journal: European heart journal | Year: 2016

Atrial fibrillation (AF) and heart failure (HF) often coexist, and patients with AF and HF have a higher risk of thromboembolic events and overall mortality compared with those with AF without HF. Additionally, the prevalence of AF increases with the severity of HF. The use of vitamin K antagonists is more unstable in patients with concomitant AF and HF, which is an independent risk factor for reduced time under therapeutic range. More recently, non-vitamin K antagonists oral anticoagulants (NOACs) have emerged as therapeutic alternatives for stroke prevention in patients with non-valvular AF, as they have been shown to be at least as efficacious and safe, with less intracranial bleeding events, compared with vitamin K antagonists. The subgroup analyses of the NOAC trials in patients with AF and HF show that the efficacy and safety of these agents are likely to be similar to those observed in patients with AF and no HF. However, many gaps in evidence exist, since HF has not been consistently defined nor used as an endpoint in these trials. In patients with HF and sinus rhythm, the risk of stroke and other thrombotic events is high, and the use of warfarin has not, to date, been shown to confer outcome benefit. The benefit of the NOAC, rivaroxaban, is being investigated in HF without AF in the ongoing COMMANDER-HF trial. This review aims to provide an insightful perspective on the use of antithrombotic treatments in patients with both AF and HF, and in patients with HF and sinus rhythm, with particular attention to the NOACs, and provides background for therapeutic, outcome and trial improvement.

Morine K.J.,The Cardiovascular Center | Kapur N.K.,The Cardiovascular Center
Current Treatment Options in Cardiovascular Medicine | Year: 2016

The use of percutaneous, non-durable mechanical circulatory support (MCS) for cardiogenic shock (CS) is growing; however, large, randomized clinical trials confirming benefit in this population do not exist. Guidelines and recommendations regarding optimal timing for MCS implementation, patient selection, device selection, and post-implantation management are beginning to emerge. A better understanding of (1) the distinct hemodynamic effects of each device option, (2) the need for early implementation of the appropriate device option for a particular clinical scenario, (3) the definition of non-salvageable CS to help clinicians know when to say “no” to non-durable MCS, and (4) best practices to monitor, wean, and optimize metabolic parameters while using non-durable MCS are required to continue improving clinical outcomes for patients with CS. © 2016, Springer Science+Business Media New York.

Kapur N.K.,The Cardiovascular Center | Esposito M.L.,The Cardiovascular Center
Current Cardiovascular Risk Reports | Year: 2016

Cardiogenic shock (CS) remains the most common cause of in-hospital mortality in the setting of acute myocardial infarction (AMI). Recent data have identified several concerning trends in the field of AMI-CS that include an overall increase in mortality, an increase in patient complexity, minimal use of acute mechanical circulatory support (AMCS) devices with the majority being implanted as a bailout option. In this review, we will discuss recent trends in CS and the rationale for the use of acute mechanical circulatory support pumps early in the clinical treatment of CS. © 2016, Springer Science+Business Media New York.

Kapur N.K.,The Cardiovascular Center | Esposito M.,The Cardiovascular Center
Heart Failure Clinics | Year: 2015

The use of surgically implanted durable mechanical circulatory support (MCS) in high-risk patients with heart failure is declining and short-term, nondurable MCS device use is growing. Percutaneously delivered MCS options for advanced heart failure include the intra-aortic balloon pump, Impella axial flow catheter, TandemHeart centrifugal pump, and venoarterial extracorporeal membrane oxygenation. Nondurable MCS devices have unique implantation characteristics and hemodynamic effects. Algorithms and guidelines for optimal nondurable MCS device selection do not exist. Emerging technologies and applications will address the need for improved left ventricular unloading using lower-profile devices, longer-term ambulatory support, and the potential for myocardial recovery. © 2015 Elsevier Inc.

Kapur N.K.,The Cardiovascular Center | Bader Y.H.,The Cardiovascular Center
Interventional Cardiology Clinics | Year: 2013

Heart failure is a major cause of global morbidity and mortality affecting nearly 24million individuals worldwide. Although the importance of right ventricular (RV) function has become more apparent over the past few decades, few therapies specifically target RV failure. Over the past 3 decades, significant advances in percutaneously delivered circulatory support devices has led to the recent development of devices specifically designed for RV failure. In this review, RV pathophysiology, device options, and clinical data exploring the utility of percutaneous RV support devices are discussed. © 2013.

PubMed | The Cardiovascular Center and Xinjiang Medical University
Type: Journal Article | Journal: Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi | Year: 2015

To investigate the distribution of 3-adrenergic receptors (ADR3) gene polymorphisms (rs2298423 and rs6986132) and its association with serum lipid in Han and Uighur populations in Xinjiang.Genotypes of the ADR 3 gene were detected in 362 Uighur and 653 Han healthy individuals who were randomly selected in Xinjiang by real-time PCR (TaqMan) method.1) Frequencies of TT, GT and GG genotypes of the rs2298423 locus were 76.5%, 22.1% and 1.4% in the Uighurs but 74.7%, 23.3% and 2.0% in the Hans. There was no significant difference noticed in distribution of genotypes between the two populations (P = 0.695). 2) Frequencies of GG, AG and AA genotypes of the rs6986132 locus were 81.5%, 16.6% and 1.9% in Uighurs but 59.6%, 33.7% and 6.7% in Hans. There was significant difference noticed in the distribution of genotypes between the two populations (P < 0.001). 3) Total cholesterol and low density lipoprotein cholesterol levels were significantly higher in GG or GT genotypes than in the TT genotype carriers of rs2298423 in the Uighur individuals (P < 0.01), but not in the Han population. Serum lipid level that including total cholesterol (TC), low density lipoproteins cholesterol (LDL-C), triglyceride and high density lipoproteins cholesterol did not show significant differences in the distribution of rs6986132 genotypes between the two populations (P > 0.05). After adjusting for factors as gender, age, height, weight, waist circumference, blood urea nitrogen, creatin, glucose, triglyceride, smoking, drinking, results from the logistic regression analyses revealed that those individuals who were carrying GG or GT genotype of rs2298423 were expected to face an increased risk for total cholesterol and low density lipoprotein cholesterol level than those individuals that carrying TT genotype in Uighur populations (OR = 3.140, 95% CI: 1.270-7.764, P = 0.013 in TC level; OR = 3.818, 95% CI: 1.761-8.280, P = 0.001 in LDL-C level). 4) The T-G haplotype appeared more frequent in the Uighurs while the T-A haplotype was more commonly seen in the Han population, respectively (both P < 0.001).The mutational frequencies of the tagging SNPs in rs2298423 and rs6986132 loci of the ADR 3 gene presented obvious differences between Han and Uighur populations of Xinjiang. G allele carriers of rs2298423 seemed to face an increased risk for TC and LDL-C level in the Uighur populations in Xinjiang.

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