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At least 19 recordsLinked to original sources

PubMed2025

Angiotensin-Neprilysin Inhibition and Left Ventricular Assist Device Therapy: Primary Results of the ENVAD-HF Trial.

BACKGROUND: The role of heart failure-specific therapies in left ventricular assist device (LVAD) recipients is unclear, and observational data suggest improved outcomes with neurohormonal blockers. OBJECTIVES: ENVAD-HF (Multicenter, Randomized, Open-Label, Parallel Group, Study to Evaluate the Use of Sacubitril/Valsartan in HeartMate 3 LVAD Recipients) sought to evaluate the safety and tolerability of the angiotensin-neprilysin inhibitor sacubitril/valsartan vs standard of care (SOC) for managing blood pressure (BP) in HeartMate 3 LVAD recipients. METHODS: ENVAD-HF was a prospective multicenter, randomized, open-label study of sacubitril/valsartan vs SOC for managing BP (mean arterial pressure goal: 75-90 mm Hg) in stable LVAD recipients with 12-month follow-up. The composite primary endpoint was time to death, deterioration in renal function, hyperkalemia, or symptomatic hypotension leading to drug withdrawal. Exploratory endpoints included clinical and biomarker assessments and patient-reported outcomes. RESULTS: In 60 randomized patients (30 in each arm), sacubitril/valsartan compared with SOC demonstrated an HR of 0.42 (95% CI: 0.08-2.18; P = 0.30) for the primary endpoint at 12 months. Two primary endpoints were reached in the sacubitril/valsartan group (1 death and 1 symptomatic hypotension event) compared with 5 in the SOC group (2 deaths, 2 worsening renal function events, and 1 symptomatic hypotension event). Numerical trends in favor of sacubitril/valsartan were noted for other exploratory endpoints, including a reduced number of BP medications (difference: -1.09 [95% CI: -1.52 to -0.66]; P < 0.0001) and a significantly better Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (improvement: +10.6 [95% CI: 2.6-18.7]; P = 0.011). CONCLUSIONS: ENVAD-HF, a prospective randomized controlled trial of angiotensin-neprilysin inhibition in stable HeartMate 3 LVAD recipients, demonstrated the safety and tolerability of this therapy in this unique population. The trial forms the basis for a pivotal trial to investigate the usefulness of HF-specific therapies in the LVAD population. (Sacubitril/Valsartan in Left Ventricular Assist Device Recipients [ENVAD-HF], NCT04103554; A multicENter, randomized, open-label, parallel group, pilot study to evaluate the use of sacubitril/valsartan in HeartMate 3 LVAD recipients, 2019-003888-22).

Humans↗

PubMedDate not supplied

Nursing management and rehabilitation of chronic ventricular assist device (VAD) patients.

With the increasing number of heart transplants performed annually and the number of available organs decreasing, more patients are being bridged to transplant by mechanical circulatory support (MCS) systems during their wait for a donor organ. The duration of assistance with MCS has also increased due to this shortage of donor organs. The Artificial Heart Program at the University of Pittsburgh, recognizing this changing population, has shifted the focus of care from acute support to chronic support of VAD patients. Providing care directed at long-term support has promoted rehabilitation and helped to improve the overall bridge experience. At the University of Pittsburgh, 34 patients were implanted with MCS devices as a bridge to transplant between June 1987 and September 1992 (Figure 1). Thirteen of these patients were supported for over 60 days. Of these, three were eventually discharged to an out-of-hospital facility six blocks from the medical center. Eleven of the 13 patients supported over 60 days were discharged following successful orthotopic cardiac transplantation. In response to this increasing duration of support in the bridge to transplant patient, the role of the nurse has changed significantly. Nursing care initially focused on acute physiologic monitoring procedures that are restricted to an intensive care setting. Today the role of the MCS nurse encompasses a much broader area including medical care, education, and patient rehabilitation. It is important to realize that these aspects of care begin when a patient is identified as a MCS candidate and continue throughout the acute postoperative phase into the chronic phase of recovery.

Heart-Assist Devices↗

PubMed2026

Initial 4-Year Experience With Microaxial Flow Pumps Within a Tertiary Centre in Regional Australia.

BACKGROUND & AIM: The Microaxial Flow Pump (MFP) is a miniaturised rotary pump that aspirates blood from the left ventricle and expels it into the ascending aorta. It unloads the left ventricle and increases mean arterial pressure and cardiac output. MFP is most commonly utilised in cardiogenic shock, for protected percutaneous coronary intervention (PCI), and for ventricular offloading in veno-arterial extracorporeal membrane oxygenation (VA-ECMO). METHOD: We conducted a retrospective review of all patients who underwent MFP insertion at John Hunter Hospital, Australia. Categorical data are represented as counts and percentages, with continuous variables described as means with standard deviations. RESULTS: Twenty-three MFP devices were inserted between September 2020 and May 2024. Five (22%) were for protected PCI, three (13%) for venting with VA-ECMO (ECPELLA), and 15 (65%) for acute coronary syndrome (ACS) and cardiogenic shock. The median age for the overall cohort was 62 years, with a 74% male predominance. Eighty percent of the protected PCI cohort were elective outpatient procedures, and there were no deaths in this cohort. The mortality in the ECPELLA group was 67%. Thirteen (87%) of the patients with cardiogenic shock presented with an anterior infarct, and 53% had cardiac arrest on admission. The overall morality in the cardiogenic shock cohort was 40%. Complications in this cohort included limb ischaemia in four patients (17%) and site bleeding in seven patients (30%). Four patients (17%) required vascular surgery intervention. CONCLUSION: Our initial experience showed the use of MFP in a tertiary centre was safe and feasible, allowing progression from protected percutaneous intervention to acute cardiogenic shock.

Humans↗

PubMedDate not supplied

A magnetically actuated left ventricular assist device.

Over the past 6 years, research has led to development of a small, lightweight, power-efficient, uniquely simple ventricular assist device driven by a magnetic actuator. Magnetic actuation permits total elimination of all mechanical motion converter components used for pusher plate displacement, resulting in a significant reduction in complexity and resultant increase in reliability. Extensive in vitro mock loop development has resulted in a left ventricular assist device (LVAD), the primary design parameters of which for the clinical prototype actuator and pump are 1) an actuator weight of 312 g, 2) actuator size of 32.5 cm3, 3) power requirements of 7.8 to 11.4 watts (60-100 beats per minute [BPM]), and 4) system efficiency of 24% to 34% and average dynamic stroke volume of 65 ml. Initial in vivo tests assessed this LVAD's performance in four sheep under three acute conditions of ventricular dysfunction. The results demonstrate that, at a pump-rate of 100 BPM, mean aortic pressure increased by 45-50 mmHg during 1) beta blockade, 2) coronary ligation, and 3) ventricular fibrillation. Pump flow ranged from 2.71 L/min to a maximum of 4.6 L/min. Acute test periods were arbitrarily set for 6 hours duration. Of the four sheep, two survived, one lived 5 hours, and the fourth lived 4.5 hours. Global fibrillation was the primary cause of failure. This initial in vivo data demonstrates the pump's ability to maintain satisfactory hemodynamic parameters of flow and pressure under three acute conditions of extreme left ventricular dysfunction in an animal model. These initial LVAD performances were encouraging. Further tests will use calves with a greatly expanded performance evaluation protocol.

Adrenergic beta-Antagonists↗

PubMed2026

Prothrombin complex concentrate (PCC) vs. non-PCC strategies for warfarin reversal in left ventricular assist device recipients: A systematic review and meta-analysis.

BACKGROUND: Left ventricular assist devices (LVADs) prolong survival in end-stage heart failure, and warfarin thromboprophylaxis is recommended to prevent device thrombosis and thromboembolic complications. When bleeding occurs or emergency surgery is required, rapid anticoagulation reversal is critical. Prothrombin complex concentrate (PCC) provides rapid reversal; however, its risk-benefit profile in LVAD recipients remains unclear. We conducted a systematic review and meta-analysis comparing PCC with non-PCC strategies for warfarin reversal in LVAD recipients. METHODS: MEDLINE, Embase, and Scopus were searched through June 2025 for studies of PCC versus non-PCC strategies for warfarin reversal in LVAD recipients. Two reviewers independently extracted data. Random-effects models were used to pool arm-level estimates and to pool head-to-head comparisons using mean differences or risk ratios (RRs). RESULTS: Eighteen studies involving 779 patients were included. Arm-level pooled estimates for PCC versus non-PCC comparators were 24.0% versus 15.8% for mortality, 16.5% versus 12.1% for thrombotic events, and 3.1 versus 5.7 for FFP units. Arm-level time to INR correction was longer with PCC overall (16.5 versus 13.6 h), driven by one elective cohort, but faster within the ICH subgroup (6.0 versus 13.7 h). In head-to-head comparisons, PCC achieved faster INR correction than non-PCC comparators (mean difference - 7.6 h; p = 0.001) and required fewer FFP units (-2.6 units; p = 0.019), with no significant difference in all-cause mortality (RR 1.14; p = 0.490) or thrombotic events (RR 1.43; p = 0.176). CONCLUSIONS: In head-to-head studies, PCC was associated with faster INR correction and lower FFP requirements than non-PCC strategies, whereas mortality and thrombotic events did not differ significantly. Given the observational evidence, wide confidence intervals, and heterogeneity, equivalent safety cannot be established, and prospective studies are needed to define the relative safety and effectiveness of the two approaches. IMPLICATIONS FOR CLINICAL PRACTICE: PCC-based strategies may be considered for urgent warfarin reversal in LVAD recipients, particularly when rapid INR reduction or avoidance of large-volume plasma transfusion is clinically important. Treatment decisions should account for the indication, bleeding severity, and underlying thrombotic risk. TRIAL REGISTRATION: CRD42024573925.

Humans↗

PubMed1992

Recovery of end-organ failure during mechanical circulatory support.

To evaluate organ recovery during mechanical assistance, respiratory, hepatic and renal function parameters of 40 patients who underwent bridge-to-transplant procedures were reviewed retrospectively. Mechanical circulatory support was indicated if the hemodynamic and clinical status deteriorated despite pharmacotherapy with catecholamines, vasodilators, and intravenous use of the phosphodiesterase inhibitor enoximone. Sequelae of cardiogenic shock such as renal, hepatic and respiratory insufficiency were not considered a contraindication for mechanical support. The analysis of preimplant data such as serum creatinine, liver enzymes and pulmonary gas exchange did not identify any predictive indicator of irreversible organ damage. Functional recovery of preexisting respiratory, hepatic and renal dysfunction was found in 91%, 90%, and 85%, respectively. Subsequent transplantation, however, was affected by the number of failing organs prior to mechanical support. Of 17 patients with isolated organ failure prior to assist, 14 (82%) were transplanted. By contrast, 9 (75%) of 12 with combined failure of two organs, and only 6 (54%) of 11 patients with clinical patterns of three failing organ systems received transplants. In all patients who underwent successful transplantation, transplantability was associated with rapid organ recovery within 10 to 15 days after initiating mechanical assistance.

Adolescent↗

PubMed2026

Percutaneous left ventricular assist device in cardiogenic shock associated with and without acute myocardial infarction: a real-world retrospective cohort study.

BACKGROUND: Percutaneous left ventricular assist devices (pLVAD, such as Impella), are increasingly used for cardiogenic shock (CS). Outcomes may differ between acute myocardial infarction-related CS (AMI-CS) and non-AMI CS due to differing pathophysiology and trajectories. METHODS: Using the USA TriNetX Network (2016-2024), we identified adults with CS treated withpLVAD. AMI-CS was defined by MI within seven days of implantation; non-AMI CS included all patients with CS not attributable to acute MI, representing heterogeneous etiologies such as decompensated cardiomyopathy, myocarditis, valvular failure, pulmonary vascular causes, and arrhythmic shock. Patients with recent coronary artery bypass graft (CABG) were excluded. Propensity matching produced two balanced cohorts (n = 2,026 each). RESULTS: Among 6,873 AMI-CS and 4,521 non-AMI CS patients, matched groups were similar (mean age 63 years, 26% female). AMI-CS had higher mortality at 30 days (hazard ratio [HR] 1.19, p = 0.002), 90 days (HR 1.13, p = 0.02), and 180 days (HR 1.14, p = 0.007). Heart failure (HF) exacerbations (HR 1.21, p < 0.001) and pulmonary edema (HR 1.23, p = 0.005) were also more common in AMI-CS. Stroke, ventricular arrhythmias, cardiac arrest, acute kidney injury, major bleeding, vascular complications, and hemodialysis were comparable. CONCLUSION: AMI-CS patients supported with pLVAD experienced higher mortality and greater HF-related morbidity than non-AMI CS.

Humans↗

PubMedDate not supplied

Human intraperitoneal response to a left ventricular assist device with a Ti-6AI-4V alloy surface.

The soft tissue reaction to long-term implantation of an intraperitoneal left ventricular assist device (LVAD) was investigated. The HeartMate 1000 (Thermo Cardiosystems, Inc., Woburn, MA) is a pneumatically driven blood pump with smooth titanium alloy (Ti-6AI-4V) outer surfaces that is placed intraperitoneally in the left upper quadrant and sutured to the anterior abdominal wall. It is being used currently as a bridge to cardiac transplant, which sometimes requires extended support times. We examined the tissue capsule that formed around the rigid circular pump housing of four LVADs (duration of implant: 61, 86, 128, and 153 days) for gross, histologic, immunohistochemical, and ultrastructural analysis. Immunostaining was performed using monoclonal and polyclonal antibodies against cytoskeletal tissue markers (vimentin, desmin, alpha-smooth muscle actin), T and B lymphocytes, carcinoembryonic antigen, factor VIII, and cytokeratins (CAM 5.2 AE1/AE3, 34 beta E12, and 35 beta H11). Direct fluorescent immunolabeling for fibrinogen was also performed to characterize cell and tissue type. Histologic analysis of the 3 to 4 mm thick capsule with white, glistening inner surfaces showed fibrovascular tissue with multipotential subserosal cells (MSCs), capillary endothelium, collagen, and a few mononuclear infiltrates. The immunohistochemical profile of the MSCs differed from myofibroblasts despite a morphologic similarity. Transmission electron microscopy revealed abundant rough endoplasmic reticulum and peripherally arranged myofilaments within the spindle shaped cells. It was hypothesized that capsule formation was initiated by fibrin deposition, followed by proliferation of MSCs and subsequent formation of fibrovascular tissue.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1992

Implantation technique for the HeartMate left ventricular assist device.

The technique for implanting the HeartMate, an intraabdominally placed, pulsatile left ventricular assist device, is described. This device, which has been developed for potential use in patients requiring permanent left ventricular assistance, is currently undergoing clinical investigation in patients requiring temporary support as they await cardiac transplantation. This clinical experience has demonstrated device safety and efficacy, even for patients requiring extended periods of support.

Abdomen↗

PubMed1992

Cardiac assistance from skeletal muscle: a critical appraisal of the various approaches.

We review here various ways in which cardiac assistance might be derived from a patient's own skeletal muscle. Calculations based on experimental data and optimistic estimates of the efficiency of the energy conversions involved suggest that the continuous assist available would be limited to about 2 litres a minute if a muscle were used to energise an electromechanical device. It would be more efficient to couple the energy mechanically or hydraulically, but these approaches still pose problems of anatomical placement, muscle attachment, fluid leakage, and cost. Unless these issues can be addressed, the use of skeletal muscle as an internal power source for mechanical circulatory assist devices will remain an unworkable concept. Configurations that couple skeletal muscle contraction directly to the circulation would be more efficient and less costly. In terms of the energy available, a skeletal muscle ventricle could be designed to provide a continuous partial assist of 1-2 l/min, with flows of up to 8 l/min sustainable for limited periods. Such an approach offers new possibilities for the surgical treatment of chronic cardiac failure.

Blood Circulation↗

PubMed1992

[Surgical treatment using percutaneous cardiopulmonary bypass in cardiac arrest patients with acute myocardial infarction].

Explore the source record for details and available documents.

Cardiopulmonary Bypass↗

PubMed1992

[Heart transplantation--indications and results].

Heart transplantation has become a standard procedure in the treatment for irreversible heart failure. Criteria for both recipients and donors have been extended. One year survival now reaches 81%. In the immediate postoperative course patients are endangered by infection. In the long-term course coronary artery disease of the transplanted heart becomes the most serious problem. Alteration of liver and kidney function due to chronic medication as well as malignancies and hypertension also occur. In case of chronic transplant failure retransplantation may be indicated. Acute cardiac failure before transplantation nowerdays can be treated by mechanical circulatory assist devices.

Follow-Up Studies↗

PubMed1992

[Schemes for implanting shovel pumps for assisted circulation].

The authors propose a design of an axial shovel pump for extracorporeal circulation. They show how to introduce it into various cardiovascular segments and make a comparative assessment of its efficacy in relation to the type and severity of heart failure, surgical access, and treatment policy.

Assisted Circulation↗

PubMed1992

New approaches for cardiac assists: "back to the future".

The treatment of the modern epidemic of coronary artery disease requires the availability of various cardiac assist devices. A review and future implications of the use of retrograde coronary venous perfusion, the intraaortic balloon, a new ascending aortic pump, variable atrial septal defect, and novel energy sources are discussed.

Aged↗

PubMed1992

The relationship between organ perfusion pressure and multiple organ failure during mechanical left ventricular assist.

The purpose of this study was to analyze the relationship between hemodynamics, especially the organ perfusion pressure (OPP = mean aortic pressure-mean right atrial pressure) and multiple organ failure (MOF) in cardiac patients receiving left ventricular mechanical assists (LVA). The subjects were 33 patients who had undergone left ventricular mechanical assists in the Department of Cardiovascular Surgery, Fukushima Medical College Hospital, from March 1985 through March 1990. OPP significantly correlated with the levels of GOT, total-bililubin (TB), BUN and serum-creatinin (s-Cr), oxygenation index (OI) and respiratory index (RI). The cardiac index and left and right ventricular stroke work indices, in comparison with OPP, did not significantly correlate with any of the above laboratory tests. These results indicate that OPP is a simple and reliable index to recognize, and also to prevent MOF during LVA. It was also found that OPP should be maintained at a level higher than 65mmHg to protect the liver, kidneys and lungs.

Adult↗

PubMed1992

[High incidence of left ventricular thrombosis and systemic embolism in patients with left ventricular assist system].

The purpose of this study was to determine the incidence of left ventricular (LV) thrombosis and systemic embolism in 14 patients with LV assist systems. Echocardiography was used to detect LV wall motion abnormalities, intracavitary smoke-like echoes and thrombosis, and the effect of anticoagulant therapy was serially examined. During full assist of the circulation, the aortic valve did not open in any patient. Smoke-like echoes were observed in 9 patients (64%) and thrombi in 8 (57%). The thrombus developed within the first 3 assist days. Systemic anticoagulant therapy decreased the thrombus size in only 3 patients, but there was a possibility of intracranial or mediastinal bleeding in other 3 patients. Systemic embolism was noted in 7 of 11 autopsy patients (64%). The characteristic finding was that there were multiple embolized organs, such as the brain, kidneys, spleen and liver, in all patients. Development of a thrombus is a serious complication in all patients with LV assist systems. However, the problem does not lie in the assist system but in the left ventricle of the patient's own heart. It is also noteworthy that systemic anticoagulation is not effective for an LV thrombus. A new method of assisting the failing heart, or a new anticoagulant delivery technique for the LV cavity to prevent LV thrombus development is needed.

Adult↗

PubMed1992

Mechanical circulatory support in the 1990s.

The current experience in bridging patients to weaning (more than 965 implants) and to transplantation (more than 544 implants) has shown the feasibility of mechanical circulatory support in patients with major cardiac dysfunction, who are unresponsive to optimal medical management. The complications are mostly related to the patient's initial condition at the time of implantation. The rehabilitation of the patient is related to both the extent of recovery from organ dysfunction and the type of device. This analysis proposes some new orientations for research. Firstly, in clinical research, definition of precise indices of the patient condition, not exclusively related to the haemodynamic situation, should allow better patient and device selection. Secondly, in technological research, precise definition of the actual clinical objectives should help in the development of various systems: for resuscitation, for bridging purposes and for long-term or permanent implantation.

Assisted Circulation↗

PubMed1992

Management of the patient awaiting cardiac transplantation.

The spectacular clinical success of heart transplantation (HTTX) in the cyclosporine era has engendered challenging new clinical problems that include long-term management of patients with severely compromised systolic function, preparation of potential HTTX recipients for major surgery followed by immunosuppression, and ethical and rational distribution of limited numbers of donated organs. The magnitude of these challenges may seem overwhelming. Fortunately, clinicians have the luxury of dealing with the issues involved one patient, and one step, at a time. The continued efforts of clinical investigators have clarified important management principles. There is a growing appreciation of the pivotal importance of mitral valve function in determining the response to medical therapy and long-term prognosis in this patient population. Enthusiasm for pharmacologic control of asymptomatic ventricular ectopy has waned; instead, the restoration and maintenance of normal atrial function has clearly taken precedence. In preparation for surgery, new endoscopic techniques offer great advantages. The use of high-technology support devices as "bridges to transplantation" has been re-examined in view of the relatively poorer short- and long-term prognosis of patients managed with these devices. Increasingly, the optimal scenario for HTTX entails transplantation of a severely compromised but medically stable patient. As specific therapy, HTTX today has relatively limited application to the vast majority of patients with heart failure (HF). Seventeen hundred heart transplants will do little to directly affect the 400,000 patients in the United States who each year develop symptomatic HF.(ABSTRACT TRUNCATED AT 250 WORDS)

Anticoagulants↗