Discharge instructions for heartmate xve patient uw health. Patientfamily education teaching protocol heartmate ii. Association of clinical outcomes with left ventricular. The stroke risk was also reduced with heartmate 3 compared with heartmate ii 10. Jude medical infinity implantable pulse generator clinicians manual pdf 5. Heartmate 3 abbott this guide is produced by iccac the international consortium of circulatory assist clinicians.
Abbotts heartmate lvad resource center provides health care professionals with tools and materials to effectuate patient. Look at the driveline exit site at least once a day. Components of a left ventricular assist device system. Heartmate 3 fully magnetically levitated left ventricular.
Pocket controller the pocket controller is a small computer. Combined anticoagulation with antiplatelet therapy is provided to prevent thromboembolism, which is a risk associated with mechanical circulatory support devices. Abbotts heartmate lvad resource center provides health care. It controls and continually checks system operation. Evolution of left ventricular assist device therapy for. The heartmate 3 left ventricular assist device lvad employs full maglev flow. The heartmate 3 has a modular cable connection near the exit site of the driveline figure 1. Following this, an insurance verification of benefits is completed. The heartmate 3 lvad is a small implantable device that is designed to support the pumping function of the heart and helps circulate blood throughout the body for patients whose hearts are too weak to pump blood adequately on their own. Echocardiographic changes in patients implanted with a. Association of clinical outcomes with left ventricular assist device use by bridge to transplant or destination therapy intent.
A high index of suspicion is required for the diagnosis of outflow graft occlusion. Tunneling lance, hm3, tunneling lance, hm3, hm3 tunneler, hm3, surgical tools, unlock tool, hm3 surgical tools, outflow pliers more. Thoratec heartmate iii product manual pdf download. The heartmate 3 lvad is part of our heart failure management portfolio. The fda has just issued clearance for thoratec corporations heartmate ii lvad left ventricular assist device to be used as a permanent therapy in patients with severe heart failure that are. Heartmate ii is a registered trademark of the thoratec corporation.
Heartmate ii left ventricular assist system instructions for use iii. The heartmate 3 left ventricular assist device lvad is a novel,intrapericardial, centrifugal. Thrombus formation arrows is demonstrated within the bend relief portion of the cannula demonstrating substantial narrowing of the crosssectional lumen. Most of the patients supported with hm3 had normal hemodynamics in a speed range of 52005600 rpm with significant improvement in lv size and shape. By postoperative day 2 or 3, patients are typically receiving therapy with aspirin 825 mg, warfarin goal inr 1. Components of heartmate ii implanted blood pump inflow conduit outflow graph percutaneous. The study showed that 86% of the heartmate 3, as compared to 77% of the heartmate ii, patients, survived to 6 months without a disabling stroke and without the need to replace the pump. The heartmate 3 lvad is a small implantable device that is designed to. Heartmate 3 ce mark clinical investigation plan full. Taken together, these data strongly support the concept that a magnetically levitated centrifugal flow device with wider blood flow gaps mitigate some of the adverse events seen with lvads.
Heartmate 3 lvad with full maglev flow technology delivers better blood. Treating patients with left ventricular assist device lvad. We are pleased to inform you that the pma is approved. Medical management of patients with a left ventricular. Heartmate 3 pocket controller guide controller key functions and alarms. The heartmate 3 left ventricular assist system lvas st.
Medical equipment thoratec heartmate 3 coring tool instructions for use manual 18 pages medical equipment thoratec tlcii instructions for use manual. May utilize manual cuff and calculate a map if patient has a palpable radial pulse assessment of the unresponsive lvad patient lvad resource materials for community providers ur medicine vad program educational resources can be found at. This study provides insight on the impact of heartmate 3 hm3 speed settings on the volumes and shape of both ventricles. The heartmate 3 received market approval in the european union in 2015 following completion of a multicenter study. Heartware lvad approved for btt heartmate 3 in trial. Heartmate iii medical equipment pdf manual download. Caring for patients with a left ventricular assist device. One year outcomes with the heartmate 3 left ventricular. Offpump implantation of the heartmate 3 left ventricular assist device through a bilateral thoracotomy approach evgenij v. Click here for heartmate 3 lvad usage guidelines, including instructions for use and. Heartmate ii the heartmate ii is a left ventricular assist device lvad that is implanted alongside the patients native heart with the purpose of pumping for the hearts left ventricle.
This document contains information andor instructional materials developed by the university of michigan health system umhs for the typical patient with your condition. Completion of the heartmate ii surgical training program is required prior to use of the heartmate ii left ventricular assist system lvas. For heart failure clinicians, the randomized evaluation of. These pumps differ in technical design, but all are. Heartmate 3 pocket controller alarm reference guide. Jude medical was recently compared to heartmate ii in a large, randomized clinical trial and found to have improved outcomes at 6 months, although thedevicecurrently remains investigational3. Heartmate 3 lvad with full maglev flow technology delivers outstanding survival and safety outcomes as demonstrated in the momentum 3 trial at 2 years. Heartmate ii left ventricular assist system lvas by. In the heartmate 3, the motor is suspen ded magnetically without any mechanical bearings. Heartmate 3 ce mark clinical investigation plan hm3 ce mark the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Treatment of heartmate ii sts patients 3 an sts was suspected when electrical continuity testing or pocket controller diagnostics revealed that all the wires were electrically intact. Caring for the ventricular assist device patient in the. Heartmate ii lvad as permanent option for heart failure. It has been vetted by experts in mcs, air medical transport, and emergency services.
Low pulsatility, high flow hvad waveforms do not conform to a single, classic appearance, and are not intended for diagnostic purposes. Heartmate 3 lvad momentum 3, the largest lvad trial ever conducted, studied the safety and effectiveness of the heartmate 3 lvad in patients with advanced refractory left ventricular heart failure and who were indicated for mechanical circulatory support with an lvad. Heartmate 3 pocket controller guide michigan medicine. View and download thoratec heartmate ii instructions for use manual online. A, longitudinal curved planar reformats of the computed tomographic angiography demonstrate a smooth curvature of the outflow cannula without acute kink. Before using ecg before using daily check or ecg recorder function, pay attention to the. Medical management of patients with continuousflow left.
Heartmate 3 left ventricular assist system catalog. A tale of two centrifugal left ventricular assist devices. This pump uses an archimedes screw design with a resultant axial blood flow pattern. Heartmate 3 lvas surgical hand tools instructions for use pdf. Heartmate 3 left ventricular assist system instructions for use ix.
Caring for the ventricular assist device patient in the community nancy m. Heartmate 3 lvas surgical tools cleaning and sterilization instructions for use pdf 0. Richards, rn, msn, ccrn, ccns, aprncns lead vad coordinator. There are two optional tools for use with the heartmate 3. A longterm, compact left ventricular assist device lvad, the heartmate iii, has been designed and fabricated, featuring a centrifugal pump with a magnetically levitated rotor. Potapov, md, phd,a,b marian kukucka, md, phd,a volkmar falk, md, phd,a,b,c and thomas krabatsch, md, phd,a,b berlin, germany video clip is available online.
Offpump implantation of the heartmate 3 left ventricular. The device has no alarms and will not sound if the measurement reading is too low or too high. To determine whether you are eligible to receive a. Manual cuff and dopplerstethoscope are usually required use manual cuff, pump to 120140mmhg. This device is indicated for providing shortterm hemodynamic support e. Abbotts heartmate lvad resource center provides health care professionals with tools and materials to effectuate patient education and awareness regarding lvad therapy. Listing a study does not mean it has been evaluated by the u. It may include links to online content that was not.
Heartmate ii medical equipment pdf manual download. Since 2006, more than 20,000 pa tients have received lvads as desti nation therapy, and this number is expected to increase. Battery button 3 button functions push battery button once and you will get the battery fuel gauge push battery button and hold and you will get a selftest when power and driveline is removed, push battery button and hold for 5. Left ventricular assist device lvad during implantation, exchange, or explantation. The multicenter study of maglev technology in patients undergoing mechanical circulatory support therapy with heartmate 3 momentum 3 randomized clinical trial.
Most pumps are now designed to be contactfree, without mechanical bearings and an impeller. The iccac is the professional society for mcs clinicians throughout the world. Thoratec corporation issued a voluntary urgent medical device correction letter to all hospitals who have patients supported with the heartmate ii lvas reminding them to monitor the expiration date of the backup battery contained within the heartmate ii pocket system controller, as specified in the product instructions. 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. The heartmate 3 left ventricular assist system is indicated for providing shortterm. It should not replace the device operating manual as a primary source of information.
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