S. Emani

PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study

BACKGROUND Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations. METHODS PREVENT was a prospective, multi-center, single-arm, non-randomized study of 300 patients implanted with HMII at 24 participating sites. Confirmed PT (any suspected PT confirmed visually and/or adjudicated by an independent assessor) was evaluated at 3 months (primary end-point) and at 6 months after implantation. RESULTS The population included 83% men (age 57 years ± 13), 78% destination therapy, and 83% Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1-3. Primary end-point analysis showed a confirmed PT of 2.9% at 3 months and 4.8% at 6 months. Adherence to key recommendations included 78% to surgical recommendations, 95% to heparin bridging, and 79% to pump speeds ≥9,000 RPMs (92% >8,600 RPMs). Full adherence to implant techniques, heparin bridging, and pump speeds ≥9,000 RPMs resulted in a significantly lower risk of PT (1.9% vs 8.9%; p < 0.01) and lower composite risk of suspected thrombosis, hemolysis, and ischemic stroke (5.7% vs 17.7%; p < 0.01) at 6 months. CONCLUSIONS Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT.

Mind-Body Medicine in Chronic Heart Failure A Translational Science Challenge

The connection between the mind and body has often been regarded by Western medicine as something ascribed to the mystical and a topic residing outside the scope of scientific thought. However, it has been a long-term integral tenet in the medical practice of many other cultures.1 It could be argued that the reliance of Western thought on the concept of dualism in which Plato, Aristotle, and other classical philosophers separated the body as a physical entity from the mind as a “spiritual” force has ultimately discouraged health care professionals from serious consideration of what has appeared to be a vague and even mysterious connection between the mind and body.2 Nevertheless, a growing body of research has progressively identified the mechanistic building blocks that demystify the reciprocal mind-body interaction and show that it is clearly a physical rather than mystical connection. Descriptions of neurovisceral changes in which readily demonstrated structural alterations in the brain, heart, and other organ systems arise in response to stress and a variety of emotional states provide further demonstration of the true organic mind-body connection. Perhaps the most abundant mechanistic data pertain to the brain-heart interaction under both conditions of health and a variety of cardiovascular disease states. The increasing body of evidence for these important interactions has in fact led to the call for dedicated integrated fields such as neurocardiology or behavioral cardiology.3–5 It is therefore important to examine the current state of our understanding of mind-body interactions including the experimental evidence identifying the physiological basis for these interactions and their impact on clinical outcomes. As will be shown, there is a significant overlap between the pathophysiologic mechanisms of congestive heart failure and the major effectors of mind-body connections. This provides the basis for potential new therapies that incorporate mind-body medicine. …

Patients with low compared with high body mass index gain more weight after implantation of a continuous-flow left ventricular assist device

BACKGROUND Patterns of weight change after implantation of a continuous-flow left ventricular assist device (CF-LVAD) can affect transplant candidacy and may influence outcomes. We evaluated changes in weight over a 24-month period from a national LVAD clinical trial database. METHODS A retrospective analysis was performed of 896 patients enrolled into the HeartMate II Clinical trials for bridge-to-transplant and destination therapy from March 2005 to January 2009. The patients were divided into 4 groups: underweight (body mass index [BMI] <18.5 [kg/m(2)]); normal (BMI 18.5 to 29.9); obese (BMI 30 to 34.9); and extremely obese (BMI ≥ 35). Baseline BMI was compared with BMI at 6 months and 24 months after implant. BMI change >10% of baseline was considered clinically significant. RESULTS At 6 months, underweight and normal-weight patients had significant increases in BMI, with effects sustained up to 24 months (p < 0.01). Underweight patients gained weight most often, with 75% showing clinically meaningful weight gain at 24 months. Obese and extremely obese patients, in contrast, did not experience weight change over the same period. Pre-albumin levels improved from baseline to 6 months in all patients. CONCLUSIONS Underweight and normal-weight patients had an increase in BMI after LVAD implantation, and these changes persisted through 24 months. The BMIs of obese and extremely obese patients remained unchanged. Nutritional status improved in all groups.

Donor selection in heart transplantation

There is increased scrutiny on the quality in health care with particular emphasis on institutional heart transplant survival outcomes. An important aspect of successful transplantation is appropriate donor selection. We review the current guidelines as well as areas of controversy in the selection of appropriate hearts as donor organs to ensure optimal outcomes. This decision is paramount to the success of a transplant program as well as recipient survival and graft function post-transplant.

Sexual function after left ventricular assist device.

To the Editor: Impaired sexual function is common in patients with heart failure ([1][1]) and following cardiac transplant. Left ventricular assist devices (LVADs) improve survival, functional capacity, and quality of life for end-stage heart failure, but data regarding their impact on sexual

Remote hemodynamic monitoring for ambulatory left ventricular assist device patients

Left ventricular assist devices (LVADs) have been shown to markedly improve survival and quality of life in patients with end-stage heart failure. However, despite ongoing improvements in survival and quality of life, significant challenges still exist in the management of these patients, including a high rate of recurrent heart failure and rehospitalizations. Similar challenges exist in the non-LVAD heart failure population as well, and recent efforts to utilize remote hemodynamic monitoring techniques to improve outcomes have shown promise. No data currently exist demonstrating extension of this benefit into the LVAD population, although a theoretical benefit can be extrapolated. Herein we review current remote hemodynamic methods and potential applications towards LVAD patients.

Multicenter Evaluation of Octreotide as Secondary Prophylaxis in Patients With Left Ventricular Assist Devices and Gastrointestinal Bleeding

Background Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. Methods and Results This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non–rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P=0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P=0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P=0.04). Conclusions Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data.

Impact of insurance status on heart transplant wait‐list mortality for patients with left ventricular assist devices

To test the hypotheses that receipt of Medicaid or Medicare (versus private insurance or self‐pay) and low socioeconomic status (SES) leads to increased mortality and lower chances of transplantation among heart transplant (HTx) candidates with bridge to transplant left ventricular assist devices (BTT LVADs).

Successful heart transplantation using a donor heart afflicted by takotsubo cardiomyopathy.

Takotsubo cardiomyopathy, also known as apical ballooning syndrome, stress cardiomyopathy, or broken heart syndrome, is a disease characterized by transient ventricular dysfunction in the absence of obstructive coronary artery disease. Herein, we present a case in which a heart with mild takotsubo cardiomyopathy was utilized as the donor organ for an orthotopic heart transplant.

Complications of Durable Left Ventricular Assist Device Therapy

Heart failure patients on durable left ventricular assist device support experience improved survival, quality of life, and exercise capacity. The complication rate, however, remains unacceptably high, although it has declined with improvements in pump design, better patient selection, and greater understanding of the pump physiology and flow dynamics. Most complications are categorized as those related to the pump-patient interface or those related to patient physiology. It is hoped that further engineering progress, and better patient selection through risk stratification, will allow for left ventricular assist device to be totally biocompatible and perform effectively, without affecting biology and homeostasis of the different organ systems.