What is a HVAD
The HVAD stands for Heartware Ventricular Assist Device and is a type of assistive heart, LVAD, that was implanted in the Netherlands from 2010 to June 2021. In 2016, HeartWare was acquired by Medtronic.
This HVAD was the second type of assistive heart that was put into use after the HeartMate II from the company Thoratec (acquired by Abbott)
The HeartMate 3 is the successor of the HeartMate II, but based on the HVAD in terms of design.
For some time it became clear that the HVAD had more and more weaknesses, from which Thoratec could learn to develop a safe pump with the same technology, the HeartMate 3.
Problem with starting pump
At the beginning of June, we received unexpected news that Medtronic had stopped implanting the HVAD! See that article here
Several issues had been identified with this pump, but the most worrisome was that on several occasions when the pump stopped for any reason, it would not restart!
This had already cost several human lives and eventually it was decided to no longer use this LVAD.
The patients who still had the HVAD at that time would be guided as well as possible and continue to receive all the attention that was there for them before that time!
Various information about the problems at HVAD:
What can you do if this happens to you!
Above you see the controller with the alarms that go with it.
On the controller is the message: 'No flow or VAD stopped swap controller'
The part is important No flow or VAD stopped: change the controller ONLY if this message is there! (see 'What to do')
If the pump still worksyou feel that as a patient the drive-line must not be disconnected!
After all, if you disconnect the controller, the pump will stop at that moment and you will cause the problem if the pump does not want to start!
Call the hospital immediately and ask for instructions!
If the pump is stopped and the patient is conscious, go to your hospital as soon as possible or call 112 and ask for an ambulance!!
Is the pump stopped and is the patient unconscious? Call 112 and replace the controller!
- Call 112
- and say it's a CPR of an LVAD patient (then the seriousness is clear and they know it is an LVAD).
- Provide the correct address with zip code, if possible ask for help from someone who will show the ambulance the way.
- Tell the EMS to contact your LVAD team, Utrecht: (088) 756 05 00; Leiden: 0651 15 90 90 (between 09:00 and 16:00) or 071-52 99 157
- Connect the spare controller to at least one full battery and/or the power cable (note: plug the power cable into the socket!)
- Place the spare controller in such a way that the drive-line can be clicked from one controller into the other in one movement
- View the instructions shown below to be as well prepared as possible
- When the pump starts up, stops the alarm and you will see on the screen the values appear that you normally see.
- The pump does not start!
- Start CPR: pump 30 times no deeper than 5 to 10 cm., 2x ventilation
- Simultaneously keep trying to get the pump working again, check if everything is connected properly and the power on both sides of the controller shows 4x green
- It is also possible to 'reset' the controller so that the restart procedure is activated. This can be done by disconnecting the drive-line from the controller and reconnecting it after a few seconds.
- The pump receives a 30x impulse from the system to start up
- Is this na 1 minute still not successful, change the controller again or…
- Unplug the drive-line, wait 2 seconds (to reset) and plug it back in, the pump will then try to start up again 30x
Below is a video with a detailed explanation of the alarms and what to do as a rescuer (in English)
- Keep repeating this if the pump won't start (Note, this has not been tried before, but it might work!)
- Call the LVAD team of your hospital: Utrecht: (088) 756 05 00, Leiden: 0651 15 9090 between 9.00 and 16.00, then: 071-52 99 157
- Say 112 has been called and informed
- Ask if they have already been in contact with the paramedics
- Ask which hospital in your area has a heart lung machine has the patient to connect to with the instructions of the LVAD team
Important information about the problem of HVAD
As of June 3, 2021, the HVAD was no longer allowed to be implanted. This was due to several problems that were observed. Since then, several problems have arisen with the pump, the controller and the batteries.
Below we would like to share this information by means of links to the relevant articles. If more information becomes known, it will be shared here.
Class I recall Pump Weld Defect FDA, USA April 28, 2022
Health Care and Youth Inspectorate, Ministry of Health, Welfare and Sport 4 August 2022;
PDF that goes with this: Welding problem pump call Medtronic
Class I recall Battery Failure FDA, USA June 28, 2022
Health Care and Youth Inspectorate, Ministry of Health, Welfare and Sport 29 June and 12 July 2022
PDFs associated with this 1 on receipt defective batteries: Battery problem receiving batteries NL
and 2 for the people who didn't receive these batteries: Battery problem other receivers NL
Publication of DAIC August 25, 2022 with extensive list of recalls and recommendations.
ProPublica with an extensive article, August 5, 2021