Heartware ventricular assist system instructions for use. The heartware lvad is a centrifugal pump creating continuous. Welcome to the mechanical circulatory support training center on medtronic academy. Fresh solutions for different activities and lifestyles was one of our primary goals. The illustration below shows the elements of the pump. Heartmate 3 left ventricular assist system, instructions for use. Implantable cardioverterdefibrillators icds are susceptible to oversensing of extracardiac signals electromagnetic interference emi. Over 2,000 patients are enrolled in heartware hvad trials. Patients and caregivers should complete a user training. Federal health regulators are warning about reports of.
Caring for patients with a left ventricular assist device. We found ways to reduce the weight, fit the lvad to your body, and make daily life easier. At the core of the heartware system is a pumping device called a left ventricular assist device lvad. The heartware lvad is also called a bridge to transplant because it is used in patients who are awaiting a heart transplant. Fda grants heartware lvad a destination therapy indication. The heart and soul of the lvad vests are the elastic shoulder straps that absorb all the weight. Heartmate ii medical equipment pdf manual download.
Evaluation of the heartware left ventricular assist device. With our new products that you can find here at lvad gear, my lvad life became sustainably simpler. Heartware left ventricular assist device pump thrombosis. Patients and caregivers should complete a user training program and demonstrate their ability to use the system. Heartmate ii left ventricular assist device lvad abbott. Heartmate ii left ventricular assist system lvas abbott. Heartware and heartmate ii left ventricular assist devices as. Heartware vad for dt therapy endurance supplemental trial.
Temporal adverse event profile following lvad implantation via a throacotomy. This pump uses an archimedes screw design with a resultant axial blood flow pattern. View and download thoratec heartmate universal instructions for use manual online. The heartware hvad system is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure. Heartmate ii, heartware lvad devices linked to reports of. Clinicians should read the entire instructions for use before system operation. A device also known as an lvad that moves blood from your heart to. Heartware vad hvad represents the latest lvad generation of substantially smaller dimensions comparing to preceding.
Medtronic buys heart failure device developer heartware for. Medtronic acquired heartware international in august 2016. Medtronic is pleased to announce our destination therapy dt indication for the heartware hvad system, and share the data that supports this important advancement in mechanical circulatory support therapy. Abbotts heartmate lvad resource center provides health care professionals with tools and materials to effectuate patient education and awareness regarding lvad therapy. Must be able to receive either the heartware hvad or control lvad. We report two cases of emi in patients that received a heartware lvad as destination therapy for advanced hf. The first left ventricular assist device lvad was implanted in 1963 by liotta and e.
The hvad system, a left ventricular assist device lvad, helps the heart pump and increases the amount of blood that flows through the body. The chart below shows all potential alarms you may see on your controller. He has a heartware lvad, so you ask the nurse to go and grab an external monitor. Minimally invasive implantation of left ventricular assist device. Heartware lvad shirt by lvad gear leading lvad clothing. Caring for the ventricular assist device patient in the. Can the patient be defibrillated while connected to the device. Heart tones cant be heard in a heartmate ii but native tones may be heard in a heartmate iii. In addition to this manual, your clinician will provide you with instructions on operating the heartware hvad system. In a heartmate ii the controller tells the pump what to do. Abbotts heartmate lvad resource center provides health care professionals with tools and materials to effectuate patient. The heartware lvad is a miniaturized centrifugal pump implanted within the pericardial space. The deal provides a shot in the arm for the struggling heartware, and gives medtronic a. Heartware hvad system educational content has a new home on medtronic academy.
Heartware left ventricular assist system instructions for use. View and download thoratec heartmate ii instructions for use manual online. Minimally invasive implantation of left ventricular assist device heartware hvad is safely feasible. Unlike the heartware lvad system or the mvad, the iv vad is intended to be positioned within the bodys vascular network and implanted by minimally invasive catheterbased techniques. The first line tells you what the alarm is, and the second line tells you what to do. The medtronic heartware hvad system includes a ventricular assist device vad that helps the heart pump and increases the amount of blood that flows through the body in patients with advanced heart failure. These field guides are free for download and can be kept with your emergency equipment in case you run into a situation that requires you to care for an lvad recipient. Heart tones cant be heard in a heartmate ii but native tones may be heard in a. This manual may serve as a reference for detailed information including specific information on device function, system setup, implant and maintenance. To power the lvad, a percutaneous lead driveline exits the abdominal wall and. We continually learn and innovate, further advancing the treatment of endstage heart failure. Caring for the ventricular assist device patient in the community nancy m.
The lvad sits inside your chest and is connected directly to your heart. Ventricular assist device indications, safety, warnings. First patients undergo tests to assess heart function and ensure theyre healthy enough to undergo surgery. The heartmate 3 lvad is a centrifugal pump that produces flow in. Medtronic has acquired heartware international, inc. Electromagnetic interference of automatic implantable. A double locking system for securing your controller. Recent studies have shown an abrupt increase in the incidence of heartmate ii device thrombosis. Transthoracic echocardiography of the heartware left.
Getting a heartware pump involves the same procedure as getting any type of lvad. The heartware ventricular assist system is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory endstage left ventricular heart failure. Sep 27, 2017 cardiology chf fda approves lvad for destination therapy indication expanded to include patients who cannot get a new heart. This heartware lvad shirt was designed specifically for the heartware system. Caring for the ventricular assist device patient in the community. Heartware is currently developing solutions to address these issues. Food and drug administration fda approval for its heartware hvad system as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants.
If you are a heartware ondemand user, your account information and course completion history have been migrated to the medtronic academy learning system. Heartmate 3 left ventricular assist system instructions for use. Medtronic heartware hvad system approved for destination. Serious and life threatening adverse events, including stroke, have been associated with use of this device. Once the iv vad is fully developed, we expect the iv vad to be about onetenth the size of the heartware lvad system. Patient must agree to participate in and comply with an improved blood pressure management program, including maintenance of a patient diary. You may at any time change the settings regarding cookies. Lvads, and should be aware of the physical and psychological needs of. Heartmate ii, heartware lvad devices linked to reports of serious problems, fda warns august 6, 2015 written by.
Aug 06, 2015 heartmate ii, heartware lvad devices linked to reports of serious problems, fda warns august 6, 2015 written by. Severe right ventricular failure as defined by the anticipated need for right ventricular assist device rvad support or extracorporeal membrane oxygenation ecmoat the time of heartware lvad screeningenrollment or right atrial pressure 20 mmhg on multiple inotropes, right ventricular ejection fraction rvef oct 30, 2012 how to change an lvad dressing. Thoratec heartmate universal instructions for use manual pdf. Updated the heartware left ventricular assist device lvad may now be used in the united states as a destination therapy in patients with endstage heart failure who are not candidates for transplantation, device maker medtronic announced wednesday. The purpose of this study is to comparatively analyze outcomes of heart transplant patients bridged to transplantation with heartware hwvad versus heartmate ii hmiivad left ventricular assist devices. Discharge instructions for heartmate xve patient uw health. Heartware left ventricular assist device pump thrombosis a shift away from ramp j.
Sep 28, 2017 updated the heartware left ventricular assist device lvad may now be used in the united states as a destination therapy in patients with endstage heart failure who are not candidates for transplantation, device maker medtronic announced wednesday. Usually no, but you will need to check with implanting center. The heartmate ii lvadheartware hvad function is sensitive to changes in blood pressure, both increased and decreased pressure. A tale of two centrifugal left ventricular assist devices. Do i need to heparinize the patient if it slows down.
The heartmate 3 lvad is indicated for providing shortand longterm mechanical circulatory support e. The heartmate ii lvadheartware hvad function is sensitive to changes in. Its used in 56 countries and serves more than 18,000 patients worldwide. Ems field guides have been developed to help you identify, troubleshoot, and provide emergency care for the lvad recipient. Introduction left ventricular assist devices lvads are increasingly used for the treatment of endstage congestive heart failure, both as a bridge to transplantation and as destination therapy 1. The most common types of lvads used at cleveland clinic are the heartmate 3 and the heartware. The medtronic hvad system features the worlds smallest, commercially available, centrifugal flow pump.
Thoratec heartmate ii instructions for use manual pdf download. The deal provides a shot in the arm for the struggling heartware, and gives medtronic a foothold in the promising lvad market. The heartmate ii left ventricular assist system is intended for use both inside and outside of the hospital, or for transportation of left ventricular assist device patients via ground ambulance, airplane, or. As many as 350 hospitals trust the heartware hvad system. Therefore, the purpose of the present singlecenter, retrospective, observational cohort study is to describe the unique findings on transthoracic echocardiography of the heartware lvad.
It pumps blood from the left side of your heart into your aorta large blood vessel that carries blood from your heart to the rest of your body. Clinical users of the heartware system should attend heartware clinical operator training, should have a working knowledge of the principles of left ventricular assist devices lvads, and should be aware of the physical and psychological needs of patients undergoing lvad support. Lvad therapy has been demonstrated to extend life, augment heart function, and improve quality of life in patients with advanced heart failure for whom the device is indicated. With the lvad gear vests, there is no need to unplug the batteries to put them into the vest. Patients are randomized to heartware vas or control lvad in a 2. Minimally invasive implantation of left ventricular assist. It pumps blood from the left side of your heart into your aorta large blood vessel that carries blood from. This site uses cookies to store information on your computer. Fda approves lvad for destination therapy medpage today.
Heartmate universal battery charger pdf manual download. Page 1 heartware hvad system patient manual page 2 quick reference guide for alarms when an alarm occurs, two lines of text appear in the controller display. This is a prospective, randomized, unblinded, multicenter, noninferiority evaluation of the heartware vas versus a control group consisting of any fdaapproved lvad approved for destination therapy. Left ventricular assist devices mechanical circulatory support. Over 26,600 heart failure patients have received the heartmate ii lvad. Learn about the heartware hvad system, an intrapericardial vad approved for destination. Heartware vas for dt trial university of utah health. After a very good initial experience with this technique it has become the method of choice in our department. The first successful implantation of a left ventricular assist device was completed in 1966 by dr. Birati, md v entricular assist device vad thrombosis is a frequent and potentially devastating complication of mechanical circulatory support. Medtronic heartware hvad system approved for destination therapy. In a heartmate iii the settings are stored inside the actual pump.
Heartware lvad approved for btt heartmate 3 in trial. The heartmate ii left ventricular assist system is intended for use both inside and outside of the hospital, or for transportation of left ventricular assist device patients via ground ambulance, airplane, or helicopter. Jun 28, 2016 medtronic has acquired heartware international, inc. By using the site, you consent to the placement of these cookies. Understanding the lvad a left ventricular assist device lvad is a continuousflow pump that connects the left ventricle to the ascending aorta via an internal cannula. Heartware ventricular assist system therapeutic goods. Can give a bolus of normal saline and transport to an lvad center. For almost a decade, the heartmate ii device abbott, chicago, ill has been the most commonly installed durable left ventricular assist device lvad in the united states, both as a bridge to transplant and for destination indications. Heartware has written to cardiologists who manage the treatment of patients with a heartware ventricular assist system providing further information about the above issues, including a patient communication to be provided to users. A 52 year old male is admitted to your icu with complications related to his lvad. With this indication, the heartware hvad pump is the only intrapericardial vad with 2 years of data that is approved for dt in. From may 2009 to december 2010, heartware lvads were implanted in 19 patients at st. This heartware controller pocket is the same system we have been using for over 3 years in all our heartware products.
808 1355 1355 908 824 1404 66 474 1569 569 12 1457 35 657 1469 830 998 72 599 606 1331 1416 857 1179 1270 1489 1181 669 340 1175 869 157 393 964 600 1388 1219 885 88