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Query: UMLS:C0018801 (heart failure)
 72,216 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The CardioWest TAH was created and initially tested at the same time as the Thoratec, Novacor, and HeartMate devices. It was designed as a permanent artificial heart and was the first-ever mechanical circulatory device to be used as destination therapy. Twenty years have passed since that early experience. Pneumatic technology is still current and being developed as in existing or new implantable Thoratec VADs the pneumatic HeartMate, and the Abiomed BVS 5000 pumps. Portable pneumatic drivers have been available since 1982, and in recent times have allowed discharge to home of substantial numbers of patients, thus reducing the length of hospital stays and making mechanical device support less expensive to society and more tolerable to patients. Within months, a portable driver for the CardioWest will be available. The documented benefits of the CardioWest TAH include rescue of: critically ill patients with advanced heart failure; patients with biventricular failure especially those with significant right heart failure, elevated pulmonary vascular resistance, or pulmonary edema; patients with renal or hepatic failure secondary to low cardiac output; patients with massive myocardial damage such as those with post-\infarction VSD or irreversible cardiac graft rejection; patients with mechanical valves or native valve disease; and patients with intractable arrhythmias and heart failure. High device outputs with restoration of normal filling pressures result in high perfusion pressures that have led to dramatic recoveries, convalescence, and return to levels of activity compatible with normal life. The average device output with the CardioWest TAH is higher than any other approved or investigational device. The reason for this resides in design simplicity this device has the shortest and largest inflow pathway. Stroke, in the authors' own series, is rare with a linearized rate of 0.068 events per patient year. If the experiences of La Pitie and the University of Arizona are combined, there has been one stroke in 25 patient years (0.04 events/patient year). Serious infections have been rare (12% of patients). No clinical mediastinitis has occurred. Drivelines have healed in tightly and never caused an "ascending" infection. There has not been a case of device endocarditis. Using a broad definition of bleeding, including takeback reoperation for bleeding, bleeding more than 8 units in the first postoperative 24 hours or 5 units over any other 48-hour period, a 25% to 36% incidence has been documented. No cases of fatal exsanguination have resulted, as there have been with the HeartMate. The incidence of bleeding as an adverse event is about 17% lower than the rate reported for the HeartMate VE LVAD, and it is about the same as that reported for Novacor and for Thoratec. Implantation of this device is relatively easy and often done (with attending help) by the authors' residents. If one follows the guidelines for fitting the device, and takes the recommended advice for implantation, hemostasis is excellent and restoration of immediate cardiac function with high flows is nearly automatic. Use of a neopericardium of 0.1 mm EPTFE at the time of implantation assures atraumatic and relatively quick re-entry for transplantation and prevents the normal inflammatory mediastinal reaction that might be desirable in a destination application. In selected patients the CardioWest TAH is the device of choice for bridge to transplantation. When a portable driver becomes available, out of hospital management of CardioWest TAH patients will be feasible and consideration of use of this device for longer term applications, (e.g., "destination therapy,") will be reasonable. A wearable driver, even smaller than a portable, will improve quality of life and expand the patient population that may be therapeutically served with this system. In short, the CardioWest TAH has come nearly full circle. It was first used as a destination device. It has since been used as a bridge to transplantation in nearly 200 patients as the Jarvik-7/Symbion TAH and, since 1993, in over 225 patients as CardioWest. The results have improved with time. Thromboembolism and infection rates have been competitive with currently available devices. Device reliability and durability have been excellent. Survival rates have been very high in a group of perhaps the sickest patients to be supported with any pulsatile device. Pneumatic technology has improved with portability and miniaturization, and there is reason to believe that it will become even better. Application of modern manufacturing techniques to this very simple device raises the possibility of significant manufacturing cost reduction, in an era of prohibitive cost for other devices. All of this establishes the CardioWest as a valuable device for any program that is seriously interested in end-stage heart disease and a likely device for permanent use in appropriately selected patients.
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PMID:Total artificial hearts: bridge to transplantation. 1279 49

Mechanical bridging to cardiac transplantation with a ventricular assist device may be a life-saving procedure for patients with end-stage heart failure. Here we report our 3 cases of patients implanted with the MicroMed DeBakey VAD (ventricular assist device). Three male patients, aged 37, 41, and 40, had end-stage left heart failure due to idiopathic cardiomyopathy and were listed for cardiac transplantation. They had progressive hemodynamic deterioration. Although Patient 1 underwent surgery, after device implantation, for bowel necrosis caused by thromboemboli of unknown origin, heart transplantation was performed 70 days after implantation. Pump thrombosis occurred in Patient 2 on the 120th day. Outflow graft ligation was performed because the patient refused a pump exchange. This patient died on the 25th day after ligation and the 145th day after ventricular assist device implantation. A heparin-coated version of the device was implanted in Patient 3, whose preoperative profound biventricular failure had been improved by inotropic medication and intra-aortic balloon pump support. Successful heart transplantation was performed 161 days after implantation. These are the 1st implantations of a left ventricular assist device in Turkey. From these cases, we have learned that the DeBakey VAD supplies adequate blood flow during the bridging period and, due to its simplicity, portability, and low infection rate, enables discharge of the patient from the hospital. However, preoperative psychological evaluation and postoperative psychological support are important for a successful bridging procedure, as is close observation of coagulation and of pump operation.
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PMID:First Turkish experience with the MicroMed DeBakey VAD. 1280 52

The AbioCor implantable replacement heart (IRH) is the first available totally implantable artificial heart. We recently initiated a multicenter trial of this device in patients with severe, irreversible biventricular failure. Patients who were not candidates for other therapies, including transplantation, were evaluated. All candidates were adults with inotrope-dependent biventricular failure, whose 30-day predicted mortality was higher than 70%. A three-dimensional computerized fit study predicted fit of the AbioCor thoracic unit in all recipients. At operation, the internal battery controller and transcutaneous energy transfer unit were placed. The AbioCor thoracic unit was placed in an orthotopic position after incision of the ventricals. There were 2 intraoperative deaths (due to intraoperative bleeding or aprotinin reaction). Four late deaths were recorded, 1 from multisystem organ failure and 3 cerebrovascular accidents. Autopsy revealed thrombus on the atrial struts of the 3 patients with cerebrovascular accident. Blood pumps and valves were clean on all patients. Significant morbidity was observed, primarily related to preexisting severity of illness. However, 3 patients recovered to the point of being able to take multiple trips outside of the hospital. Two patients were discharged from the hospital, with 1 patient being discharged home for more than 7 months. No significant device malfunctions or multi-system organ failure device-related infections were noted. The AbioCor IRH may be effective therapy for patients with end-stage heart failure. Many milestones have been achieved in the initial trial in humans, including the successful discharge of a patient to home and no significant device malfunctions. The occurrence of stroke is likely related to the presence of thrombus on the atrial struts and may be decreased as these atrial struts have been removed for future clinical implants.
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PMID:The AbioCor implantable replacement heart. 1282 Jul 41

In patients hospitalized with decompensated life-threatening heart failure, the impact of newer pharmacologic therapies and mechanical circulatory support has not yet been realized, except for those who are bridged to cardiac transplantation. For long-term support of transplant-ineligible patients who have severe biventricular failure that is refractory to optimized pharmacologic therapy, replacement of the natural heart with a totally implantable mechanical replacement heart, capable of producing blood flow of up to 8 to 10 L/min, may become the most well tolerated and effective treatment. This article summarizes the current status of the first generation implantable replacement heart (AbioCor trade mark, ABIOMED. Inc., Danvers, MA). With regard to optimizing the further enhancement of treatment options for end-stage heart failure and other life-threatening illnesses, the pharmacodynamics-like principle of therapeutic efficiency should play a role in the development of both drugs and devices. In keeping with that principle, we recommend that adjusting a product's design input requirements to maximize the therapeutic effect per exposure and;to separate the cumulative therapeutic effects of the product from the cumulative adverse effects (of the product, and of the comorbid disease processes in the patients treated) should be part of the good product development process for any therapeutic product.
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PMID:Therapeutic potential of implantable replacement hearts. 1472 59

The role of biventricular mechanical support (assist or replacement) is important for the management of severe biventricular cardiac failure. One only has to look at the role of cardiac transplantation to realize the benefit of a natural therapy to end-stage heart disease. Although the technology today is not that different from the technology that existed a decade ago (ie, BioMedicus, BVS 5000, Thoratec, CardioWest), the application of it and the experience gained by it have allowed surgeons to improve the chances of a positive outcome. In terms of new technologies for biventricular mechanical support, the totally implantable versions of a VAD (eg, Thoratec IVAD) or the totally implantable TAH (eg, AbioCor) are promising technologies that add to the spectrum of devices as destination therapy or alternatives to transplantation. And lastly, the role of the Berlin Heart as a tool for the management of biventricular failure in pediatric patients may be realized in the United States in the near future. In conclusion, the treatment of biventricular failure (acute or chronic) with assist or replacement technologies has gained widespread acceptance in the medical and surgical communities. It is now time to use these technologies wisely in an effort to treat the worldwide epidemic of congestive heart failure.
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PMID:Biventricular mechanical replacement. 1505 95

In a cardiological department of a non-referral hospital responsible for 80,000 inhabitants with 2500 in-hospital patients and 1500 out-hospital patients per year, the prevalence, symptoms and prognosis of arrhythmogenic right ventricular dysplasia-cardiomyopathy (ARVD/C) were examined retrospectively. From 1997 to 2002, ARVD/C was diagnosed in 35 females and 45 males (overall prevalence 1 in 1000 inhabitants) with a mean age of 45.6 years. Symptoms were chest pain (80%), palpitations (60%) and syncopes (30%), and clinical findings were repetitive ventricular premature beats (50%), supraventricular arrhythmias (30%), ventricular tachycardia (20%), aborted sudden death due to ventricular fibrillation (1%), right heart failure (4%), biventricular heart failure (1%) and high grade AV nodal block (4%). Endomyocardial biopsies were not performed. Aborted sudden death occurred in only one patient (0.3%) before the diagnosis was made, annual heart failure rate was 1%. No deaths appeared in a follow-up of 1-5 (mean 2.4) years with clinical assessment as the basis of diagnosis. The prevalence of ARVD/C is much higher and the prognosis better than expected from results of reference centers.
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PMID:Prevalence of right ventricular dysplasia-cardiomyopathy in a non-referral hospital. 1556 39

Temporary aortic counterpulsation is used routinely for the management of cardiogenic shock. By the perseverance of several investigators, permanent aortic counterpulsation is close to becoming a clinical reality. The initial clinical experience with permanent aortic counterpulsation (KCV) has demonstrated that it can be implanted with very low peri-operative morbidity and mortality. It is a novel non-obligatory device that has several advantages over other existing devices. There is no need for anti-coagulation and no valves or internal electronics that could fail and force VAD replacement. The control algorithm is simple, as the device is triggered "on-demand" by the electrical activity of the native heart. Furthermore, it is non-obligatory, so it can be turned on/off at will by the patient without increasing the risk of thromboembolic events. The disadvantages are that it provides only "partial" support. It increases cardiac output by approximately 40% depending on the afterload condition of the patient. It depends upon native heart activity to function and cannot be placed in patients with severe biventricular function, uncontrolled tachyarrhythmias, or with native valvular disease. However, the degree of support obtained seems sufficient to reverse the heart failure syndrome, improve end-organ dysfunction and remove inotrope dependency. The KCV is designed for intervention in NYHA class IV patients before there is severe biventricular failure or lack of any myocardial reserve. It would not be an acute recovery device or one in which IABP pumping does not improve hemodynamics. The KCV can be considered equivalent to a mechanical, permanent, non-energy depleting inotrope and may have a role in improving the length and quality of life in patients with end stage heart failure. By treating advanced CHF early, the KCV may reduce the number of patients progressing towards cardiac replacement therapy with transplantation or a total artificial heart.
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PMID:The quest for permanent ventricular assistance: the role of aortic counterpulsation. 1567 78

The AbioCor artificial heart (Abiomed, Inc., Danvers, MA) represents the latest technologic advancement in the quest for a total heart replacement system. The AbioCor is an electric heart with fully implantable components. The Food and Drug Administration approved a clinical trial in January 2001. The clinical trial was designed as an initial feasibility study to determine the safety and efficacy of this first generation system. The study criteria include end-stage adult heart failure patients who are not transplant candidates. These patients have biventricular failure with a predicted 30-day life expectancy of less than 30%. On July 2, 2001 the first AbioCor device was implanted. Six other patients have undergone implantation to date. Four of the seven have been successful as defined by the study parameters of 60-day survival with improved quality of life. Two patients were discharged from the hospital. Outpatient activities were possible in four patients. There have been no device malfunctions and no device-related infections. The trial is active and enrollment is ongoing.
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PMID:The AbioCor totally implantable replacement heart. 1578 82

Adaptive cardiac binding, a new surgical procedure for advanced heart failure, allows a gradual increase in compression on the dilated heart, with separate loads on the left and right ventricles. A canine model of biventricular heart failure (anastomosis between the carotid artery and jugular vein and doxorubicin administration) was created. Twenty-four dogs were divided into 4 groups: control, adynamic cardiomyoplasty, plastic cardiac binding, and adaptive cardiac binding. In the adaptive cardiac binding group, fluid was added (35, 15, and 10 mL) to each side of the pouch at weeks 1, 2, and 3. Left ventricular ejection fraction was 59%+/-4% before induction of heart failure and 27%+/-2% 6 weeks later. Immediately after the main operation, left ventricular ejection fractions were 35+/-3% (cardiomyoplasty), 34%+/-4% (plastic cardiac binding), and 35%+/-4% (adaptive cardiac binding). Four weeks later, left ventricular ejection fraction had not changed in the cardiomyoplasty (37%+/-3%) and plastic cardiac binding (32%+/-2%) groups, but significantly increased in the adaptive cardiac binding group (48%+/-5%); it had decreased to 23%+/-4% in controls. Adaptive cardiac binding is a promising new surgical approach for patients with end-stage heart failure.
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PMID:Adaptive cardiac binding: a new method for treatment of dilated cardiomyopathy. 1630 24

Children with heart failure unresponsive to medical therapy are left with few options for survival. Pulsatile paracorporeal ventricular assist devices are life-saving options for such patients, allowing for bridge to transplantation or cardiac recovery. From March 1997 to July 2004, 12 patients underwent implantation of Thoratec biventricular assist devices (BVADs) for refractory heart failure. Mean age was 14.9 (range 7-20) and mean BSA was 1.7 (range 1.1-1.9). Indications for support included end-stage cardiomyopathy (n=10), myocarditis (n=1), and postcardiotomy heart failure (n=1). Preimplant variables included 50% of patients requiring mechanical ventilation (mean 4.2 days), hyperbilirubinemia in 58%, and acute renal failure in 50%. Mean duration of support was 64.5 (range 2-175) days. Overall survival was 83%, with nine patients successfully bridged to transplantation (75%). One patient exhibited recovery allowing for device explantation, and two patients died while on BVADs. Complications included bleeding requiring reoperation in 25% (n=3), stroke in 8% (n=1), driveline infections in 17% (n=2), and device malfunction in one patient. Pulsatile paracorporeal BVADs can be used successfully in children and adolescents with heart failure. These results warrant consideration of using available miniaturized technology in the United States for the support of smaller children with intractable biventricular failure.
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PMID:Pulsatile paracorporeal assist devices in children and adolescents with biventricular failure. 1632 2


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