Dual Coil leads are still on the top line but single coil ones are rapidly approaching.
Posted: January 6, 2014 Filed under: eHealthCare, Medical Devices Leave a commentWith NayaMed you are a winner in both cases.
The new NayaMed single coil leads with DF-4 connector
One of the objectives of NayaMed is to offer to physicians a streamlined offer of devices and leads, bringing to market the products covering all the needs of the big majority of patients. In this respect the initial focus was on the high voltage leads with DF-1 connection and on the dual coil leads with DF-4 connector.
There is no doubt in the last 20 years dual coil leads have been preferred and until recently in most part of the world the usage of single coil leads were not more than 25% [1]. Probably the 1st reason in choosing by default the dual coil system is the results of some studies performed in the nineties, where it appears a lower DFT was demonstrated in ICD systems with 2 coils [2][3][4].
Except those early trials, there are recently more and more evidence showing that no difference was found between single coil vs. dual coil for the 1st shock arrhythmia termination for VT / VF and there is clinically equivalency in the 1st shock efficacy [5] especially if we think about the new devices on the market with 35 Joules delivered energy.
In 2003 already, Rinaldi and all. concluded there is no significant difference in DFTs between single coil and dual coil leads in the same population. The article is also enquiring about the disadvantages a dual coil lead could eventually have; promoting more fibrosis, leading to more risky and difficult extractions [6].
So we can ask why implanters worldwide are still using mostly dual coil leads despite this recent evidence. First of all, I think changing habits is not easy, than when you have good experience and no problems with an ICD lead you are used to stick to it. Then when you implant a dual coil lead you always have more options in case of a higher DFT and this is actually true as a dual coil lead gives you the option of 3 shocking vectors (RV to SVC + CAN, RV to CAN, SVC to CAN) while a single coil gives you only one option (RV to CAN). Who can do more, can do less also…
Also, there is generally no (or no more) diameter size difference between the single coil and the dual coil leads from the same family and probably most of all, when you are implanting a lead you don’t really think at its extraction.
In the last 10 years, the number of ICD implants significantly increased [7] passing in Europe from 38 implants per million in 2000 to 252 implants per million in 2010, thus more and more people being actually saved from dying due to Sudden Cardiac Death (SCD).
This big increase in the number of implants brought an increase in the number of technical issues related to the ICD system, more precisely issues with the high voltage leads, those one being considered the “weakest link” of the ICD system [8]. Who says lead problems says lead extractions and this is the moment when potential disadvantages of a dual coil lead start to be more visible bringing the fibrosis and the increase risk extraction on the table. The centers performing lead extractions started to implant more and more single coil leads.
This year, Aoukar and all. published an article called “No benefit of a dual coil over a single coil ICD lead: Evidence from the Sudden Cardiac Death in Heart Failure Trial” and to our knowledge it is the only article where other aspects than the arrhythmia termination were analysed. The base of the article is the SCD-heft trial and in this specific analyse the authors compared different clinical aspects between the populations with single vs. dual coil ICD leads implants. The results are the following: no statistical difference in SCD risk, in the rate of inappropriate shocks, in the 1st shock efficacy, in DFT test energies and above all no statistical difference in mortality between patients implanted with a single coil versus a dual coil lead [9].
Following those evidences that are completing the ones founded since 10 years it is normal and expected that the number of implants with single coil leads to increase. In 2012, in Sweden 59.4% of all the ICD leads were single coil.
This is why, in the ease of their offer NayaMed decided to freshly add a DF-4 Single coil lead to their portfolio; ND X4 01. It is an active fixation lead with silicone insulation and polyurethane overlay.
Earlier I was mentioning the ICD lead is probably the weakest link on the ICD system. Well with this in mind we decided to have a stronger link. Similar to its “older sister”, ND X4 02 (dual coil lead with DF-4 connector), the ND X4 01 is based on a lead model with more than 10 years of proven performance.
They are both meant to be implanted with any standard ICD with DF-4 header on the market, specifically with our dual or single chamber defibrillators, ND X4 DR and ND X4 VR.
Dr. Paolo Diotallevi
Eng. Alexandru Trif
Using telemedicine to implant ICDs
Posted: June 14, 2013 Filed under: Medical Devices | Tags: Dr. Natour, Heidelberg, ICDs, implant, Remote Technical Support, telemedicine Leave a comment
Heidelberg Private Clinic’s first NayaMed Remote Tech Support experience with Dr. Med. M. Natour and personnel.
Dr. M. Natour, MD, FESC, EC is a specialist in internal medicine with a focus in Cardiology and also the director of Heidelberg Private Clinic (HPK). This modern medical institution utilizes its cardiac catheter laboratory and operating room to deliver medical device implantations, as well as ablation therapy, coronary angiography, balloon dilatation (PTCA) and stent implantations. The outpatient clinic manages the complete diagnostics and therapies in the field of cardiology, such as echocardiography at rest, stress-echocardiography and transesophageal echocardiography (TEE), electrocardiograms (ECG), rest and stress-ECG and electrocardioversion.
In early April this year, during the Congress of German Society of Cardiology in Mannheim, Dr. Natour experienced the NayaMed Remote Technical Support (RTS) at our congress booth. Excited about this new technology, he decided to use this telemedicine solution during a NayaMed ICD implant back at his private clinic in Heidelberg.
After the implant, we asked his opinion on not only our technology but also our service. Here’s what he had to say:
NayaMed: Can you briefly describe the implant you did today: the patient indication and a general description of the procedure?
Dr. Natour: The implanted patient is 70 years old and a primary prevention patient. We implanted an ICD to prevent sudden cardiac death due to ventricular fibrillation because he is suffering from a very low ejection fraction.
We did it today and it was very good. It’s our first time doing an implant like this – with the RTS. I was very impressed as it went very easily. Thank you for your support…for being with us.
There’s nothing that I didn’t like. To be honest, it was very good! It was going as it should…it took something like 40 minutes, and to implant a dual-chamber ICD in 40 minutes is a good time. I like it!
NayaMed: For you as a user, did anything change for this implant compared to other ICD implants where a Technical Advisor was physically present in the procedure room? How confident did you feel knowing that you had a technical expert from Lausanne guiding the programmer user?
Dr. Natour: Let’s answer the second part of the question first: I did feel really confident having you in our operation room to support us because it’s the first time dealing with ICDs from NayaMed. So it’s a good feeling to know there’s an expert who may help us if there’s a need to have it. On the other hand, it was very impressing to work that way [remotely via the RTS]…and to communicate with someone from Lausanne and to know it is good for the future – it would be saving time and maybe also money to work this way because we don’t need to wait until someone comes from the company. We have support if we need it – so we can do it this way.
NayaMed: How easy was it for you and you staff to install the RTS system?
Dr. Natour: Once again, thank you for your support – for being here and helping with that – but I think it’s not a big deal to install it by ourselves. For the first time, it wasn’t clear what my staff should do, but actually if you look at the system and the device: connecting two cables in the right place is not a big deal – so I don’t think it will be a big problem in the future. Also, you are always available, so we can always contact you.
NayaMed: How open do you think your staff is to gaining autonomy and knowledge in performing tasks initially performed by industry representatives, knowing that they can always be guided by a Technical Advisor in Lausanne?
Dr. Natour: My staff are very open-minded and supportive of us doing new technological things. But it’s always a challenge for them and the physicians’ team to work with new things. So knowing we have support in case we need it is also very good. It was a new experience also for all of us to work that way. As you saw the face of Mrs. Becker [the nurse who ran the Analyzer during the implant]: She was happy to use the RTS and she was happy to complete the tasks necessary for the implant!
NayaMed: Do you see advantages to a support solution in which a representative doesn’t have to be in the hospital?
Dr. Natour: We are in a lucky position when we don’t have to pay a lot of money when a representative is supporting us in the hospital. But I think there are clear advantages for some places and hospitals where they have to pay for the service. This will be a very good alternative to that – as long as it’s not complicated to work with it. The service is very good, so I think it will be a step for the future.
NayaMed: Where do you see the industry heading as it relates to the growing support burden of device patients?
Dr. Natour: I think the industry and the device companies have to adapt their search to the situation with the patients because they are getting older, and they live longer – which is good but they have a lot of disease so you have to be aware of that disease and to go with the time and with the patient. To develop new devices and new possibilities to watch them and monitor them because if they get older they will not be able to visit our hospital, for example, and they will have to stay at home — so the device should be able to give me some information via telemetry.
NayaMed: From them at home?
Dr. Natour: Yes, and, for example, not only the device data. The device should support me and provide me with information about their current situation: their weight, their blood pressure, maybe their BNP…all those things…these would really be a big help – both for patients and for doctors.
NayaMed: What is the single most important advantage you see with the RTS?
Dr. Natour: I think it’s a real advantage to work with new technology. I love to work with new technologies and to update my clinic. And this option [RTS] to work with is, for me, a kind of change – that one accepts to do the implant this way. Besides this, you save a representative from the industry. You save money. You save time waiting for them because they may be somewhere else and helping by implanting at another hospital. So we can start and do it by ourselves.
NayaMed: Would you feel confident in the future having the majority of implants through RTS?
Dr. Natour: Well, I think I was a bit not confident for the first implant. But the RTS procedure went very well, and I’m feeling good and I really feel confident. I don’t think there will be a problem to deal with that.
Alexandru Trif
NayaMed Product Manager
How NayaMed is revolutionizing the medical device industry
Posted: April 29, 2013 Filed under: Infographic, Social Media, Video | Tags: RSA; Pacing; online; technology; ICD; IPG; business model Leave a comment
See how NayaMed is revolutionizing the medical device industry :
Click on the link below to read the “A Day With NayaMed” interactive eBook, and to meet many of the characters in this eBook http://bit.ly/12iWRww
Join the talk on LinkedIn : “NayaTalk – Cardio” : http://linkd.in/XCOYT9
– Follow us on Twitter : http://bit.ly/14Xv0EV
– Like us on Facebook : http://on.fb.me/ZN1rxY
– Read our blog : http://bit.ly/10SBnnJ
– Please your eyes on Visua.ly : http://bit.ly/16R6DVQ
This video was produced by Nayamed International Sàrl
Concept: Frederic Briguet Design: Edouard Ratiarson, MemeBoutique
Reviewers: Mary Soranno, Arnaud Martin.
“The content of this video is informative only. It does not contain nor replace any medical diagnosis. For medical diagnosis, you should always contact your healthcare professional. Always talk with your doctor about diagnosis and treatment information. Bear in mind that all products/therapies/procedures carry risks. This product/therapy/procedure is not right for everyone. Contact your doctor to see if it is right for you. A prescription is required.”
NayaMed 