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Dr. Victor Sanfins is a cardiologist at Hospital da Senkora da Oliveira in Guimarães, Portugal, and a specialist in implantable electronic cardiac devices. Speaking to Cardiac Rhythm News at the 2019 annual congress of the European Heart Rhythm Association (17–19 March, Lisbon, Portugal), Dr. Sanfins detailed his clinical experience with BIOTRONIK’s Rivacor ICDs and CRT-Ds, specifying numerous benefits for both patient and practitioner. He emphasises how the device programmability and longevity offers a patient-specific solution requiring fewer interventions. This increases effectiveness while reducing risks.
“Every patient is a different case”
Dr. Sanfins mentions that the small size and smooth shape of Rivacor devices make them better suited to a patient’s anatomy. He explains, “A device not well-suited to the human anatomy can easily harm the skin, and this is especially true for devices that are too large for the patient.” Rivacor ICDs and CRT-Ds are 10mm slim, with a smooth, elliptical and body-friendly BIOshape, designed to facilitate the insertion procedure,1 reduce skin pressure,2 lower the risk of skin erosion and improve patient comfort.3 In addition, Rivacor devices are the smallest, slimmest devices approved for 3T full-body MRI scans.4
In addition, Dr. Sanfins says Rivacor devices take the individual clinical needs of each patient into account. CRT AutoAdapt provides continuous CRT adaptation, automatically adjusting to changes in patient condition every minute. Auto LV VectorOpt provides automatic threshold measurements across 20 vectors5 in less than 2.5 minutes.6 He continues: “To have a device with so many features that we can individualise is excellent for both patient and physician.”
“It is important to take into account factors ranging from the size of the patient to their professional activity, as every patient represents a different case,” notes Dr. Sanfins, elaborating that earlier on in his career, “there was no choice at all. Everything was already programmed. Thirty-five years later, the Rivacor devices have many features that we are able to individualise for each specific patient.” Additionally, “the disease is not always the same. It changes and we have to fine tune the device for every single stage of the disease, which is something we can now do with Rivacor ICDs and CRT-Ds.”
“The risks are greatly reduced”
According to Dr. Sanfins, extended battery life is one of the key benefits of Rivacor devices for both patient and practitioner. Rivacor ICDs have a battery life of up to 15 years.7 This longevity means that fewer box replacements are likely to be needed, meaning fewer procedures for patients, potentially reducing risks, complications and costs. Dr. Sanfins tells Cardiac Rhythm News that “battery life is very important for physicians and patients because you can reduce the number of interventions. The risk of infection doubles at any intervention and so if you can reduce the number of interventions, you will have a lower risk of infection overall.” He goes on to say that battery longevity also decreases the cost of therapy, as fewer devices will be needed during the lifetime of the patient.
BIOTRONIK Home Monitoring helps physicians detect AF earlier, adds Dr. Sanfins. When CRT-Ds are used with BIOTRONIK Home Monitoring, a clinically-proven >60% reduction in
all-cause mortality has been found (INTIME study).8 Home Monitoring works via a smartphone-sized ‘plug in and go’ CardioMessenger Smart mobile unit, which is quick, easy to use and transmits data without any patient involvement. QuickCheck gives access to patient data typically within three to four minutes for more efficient treatment and greater piece of mind for patients.
Dr. Sanfins details a number of Home Monitoring benefits, a feature currently used by around 1,000 patients at his hospital. He comments, “Home Monitoring reduces many risks, as we can only give medication─in particular to prevent stroke─when we know that AF exists. Remote monitoring, which includes BIOTRONIK Home Monitoring, reduces mortality because, for example, with the ‘Heart Failure Monitor’ physicians can detect an increasing amount of liquid in the lungs, which is a sign of cardiac decompensation. You can detect this before the patient exhibits any clinical symptoms and you can then call the patient in and prescribe the right medication. This can help to prevent major complications.”
“We can intervene very quickly”
Dr. Sanfins says Rivacor devices allow physicians to trigger the collection of information remotely, thanks to the QuickCheck feature. “In case of a symptomatic event, we can get feedback from the device almost immediately and therefore intervene very quickly if needed, which is crucial for optimal patient care.”
The final feature Dr. Sanfins highlights is ProMRI. All Rivacor devices feature ProMRI, which gives patients full and uncompromised access to 3T MRI with full body-scanning and no exclusion zone. MRI AutoDetect senses MRI environments and selfadjusts, suspending tachycardia therapy for the duration of the scan only. This can be activated with a single visit to the physician and has a 14-day window for planning. Dr. Sanfins tells this paper this is a very important feature of Rivacor devices.
“With great advances in high-resolution imaging with 3T MRI, patients are undergoing MRI scans at an increasing rate. Consequently, there is a greater burden on clinics that have to re-program ICD and CRT-D devices before and after patients go in for MRI scans. With MRI AutoDetect, we can cut down on some of these re-programming steps, ensuring optimal therapy for the maximum amount of time, while also reducing the burden on patients, cardiologists and radiologists.”
* Acticor/Rivacor is the new generation of ICDs and CRT-Ds from BIOTRONIK, recently launched in Europe, in the USA and in Japan. Devices brands and models available may vary from one country to the other. In this interview, Dr. Victor Sanfins is referring to Rivacor ICDs and CRT-Ds, which are the devices commercialised in Portugal.
1. Post-Market observation; final-report, March 1, 2019. Data on file.
2. Device shape analysis, February 2019. Data on file.
3. Post-Market observation; final-report, March 1, 2019. Data on file.
4. As part of an MR conditional system.
5. QP models only.
6. Post-Market observation; final-report, March 1, 2019. Data on file.
7. Acticor/Rivacor VR-T Standard conditions. 15.4 years @ 40 ppm; 0% pacing @ 2.5V/0.4ms; 500 Ohms; 2 max. energy shock/year. Data on file.
8. Hindricks G et al. Lancet. 2014, 384(9943).