Patients and their ICDs – Smaller, smarter and MRI-compliant

Patients and their ICDs – Smaller, smarter and MRI-compliant

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Cardiology

Introduction

Implantable cardioverter-defibrillators (ICD) are increasingly being used worldwide and also in developing economies. The latest World Survey of Cardiac Pacing and ICD’s (2009) covering more than 80% of all pacemakers and ICDs implanted, shows this significant increase, expectedly in Europe and America, but also in the Middle East and Africa.1

A more recent survey on the use of cardiac electronic devices in Africa over the period 2011-2016 has shown that South Africa performed 132 ICD implants per million of the population annually during this period.2

As technology advances, more patients are becoming eligible for implantation and are set to benefit from this additional cardiac protection.

Launch in South Africa of World’s smallest 3T full-body ICD and cardiac resynchronisation therapy-Defibrillator (CRT-D) devices [subhead]
The need to offer ICD’s with greater longevity, reliability and ease of implantation with least patient discomfort is now being met with the launch recently in Europe of the World’s smallest 3T full-body MR conditional ICD and CRT-D devices. These devices will soon be released in South Africa (Link to video).
One of the most important clinical features of these new devices (Rivacor range) is their extended battery life with up to 15 years for the ICD’s3 and nine years for CRT-D’s.4 This lowers the need for device replacements, resulting in reduced risk and reduced distress to patients and fewer procedure costs.

Focus on the CRT-D device

In 2013, South African centres implanted 790 CRT-D devices (CRT-D and CRT-Pacemakers); an implant rate of 14.5 per million population.2

A further unique characteristic of this Rivacor device is its bioshape, ultraslim 10mm design which lowers the risk of skin erosion, achieving a greater patient comfort rating. For physicians, the slenderness of this family of devices plays a key role in easing the insertion procedure and improving how the device looks after implantation.

Also for clinicians and patients, the extended longevity and effectivity of these devices is reassuring, as CRT patients are exposed to a higher risk of complication than single-or dual-chamber ICD patients (Table 1),5 as can be seen from this 2007-2009 prospective study.

Rates of major (top)and minor (bottom)45-day complications by defibrillator type.
CRT-D = cardiac resynchronization therapy defibrillator; ICD = implantable cardioverter-defibrillator. Figure 1. Rates of 45-Day Complications by defibrillator type

Home monitoring and improved clinical outcome [subhead]

These devices offer continuous home monitoring. Cardiovascular data from the Rivacor devices can be transmitted to the physician on a daily basis with programmable alerts about relevant changes in patient health and device status. A randomised controlled trial of this alerting system (In-Time) has demonstrated a more than 60% reduction in all-cause mortality when these CRT-Ds are used with Home monitoring.6 In ICDs, the home monitoring facility has been clinically shown to help physicians detect atrial fibrillation earlier7, as well as reduce the number of inappropriate shocks by 90% and related hospitalization rates by 73%.8

The value of this In-Time approach has been included in the 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure (Table 1) using these devices.

Table 1. Recommendations of exercise, multidisciplinary management and monitoring of patients with heart failure9

Class

Level

Multiparameter monitoring based on ICD IN-TIME approach may be considered in symptomatic patients with HFrER (LVEF ≤35%) to improve clinical outcomes

IIb

B*

*Level evidence B: data derived from a single randomised clinical trial6 or a large non- randomised study.

[Pull quote] “In ICDs, the home monitoring facility has been clinically shown to help physicians detect atrial fibrillation earlier, as well as reduce the number of inappropriate shocks by 90% and related hospitalization rates by 73%.”

Continuous CRT optimisation [subhead]
An important feature of this CRT-D device is its ability to autoadapt to fit patient’s individual needs and provide continuous CRT adaptation – automatically adjusting to changes sensed in a patients’ individual needs and provide continuous CRT adaptation every minute (Figure 2).10 This provides great peace of mind to patients.

Figure 2. CRT AutoAdapt Provides Continuous Optimization. Automatically Adjusting to Changes in Patients’ Condition10
(LAYOUT: Please remove reference 1 inside figure)

Autodetection of MRI scanning [subhead]
Over the last decades, the number of Magnetic Resonance Imaging (MRI) scans has doubled every 5 years. It is estimated that 28% of ICD patients will have an indication for MRI scanning in a four-year period with more than one-third of patients needing more than one scan.11 The autodetect sensor of this device senses MRI environments and self-adjusts suspending tachycardia therapy for duration of the scan only. This facility can be activated with a single visit to the physician and has a 14-day window for planning. It can be used for 3T high-resolution MRI scanning and full-body scanning.

Conclusion

New technology is ‘game-changing’ in the management of heart failure and arrhythmias. As implantable devices become easier to implant, monitor and last-over-time, costs are reduced in surgery, in replacement procedures and hospitalisation over time. Patients

wearing these devices for a decade and more are now able to achieve an improved quality of life, while physicians are better placed to deal with the complexities of caring for these patients and any co-morbidities that may occur over time.

References

  1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009–a world society of arrhythmia’s project. Pacing Clinical Electrophysiol 2011: 34(8): 1013-1027. doi: 10.1111/j. 1540-8159.2011.03150.x https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1540-8159.2011.03150.x
  2. Bonnya,NgantchaM,JeilanM,etalStatisticsontheuseofcardiacelectronic devices and interventional electrophysiological procedures in Africa from 2011 to 2016: report of the Pan African Society of Cardiology (PASCAR) Cardiac Arrhythmias and Pacing Task Forces. Europace. 2018; 20(9):1513-1526. doi: 10.1093/europace/ eux353.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6123943/
  3. 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.
  4. Acticor/Rivacor HF-T QP, 9.3 years @ 60 ppm; RA 15%, RV/LV 100% pacing, RA/RV/ LV @ 2.5 V/0.4 ms; 500 Ohms, 2 max. energy shocks/year. Data on file.
  5. LeeDS,KrahnAD,HealeyJS,etal.EvaluationofEarlyComplicationsRelatedtoDe Novo Cardioverter Defibrillator Implantation: Insights From the Ontario ICD Database. J Am Coll Cardiol 2010; 55(8): 774-782. https://www.sciencedirect.com/science/article/pii/S0735109709039394? via%3Dihub
  6. HindricksG,TaborskyM,GliksonM,etal.Implant-basedmultiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014; 384: 583-590.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61176-4/

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  1. VarmaN,EpsteinAE,IrimpenA,etal.Efficacyandsafetyofautomaticremote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation 2010; 122(4): 325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.110.937409? url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
  2. Guedon-Moreau,LacroixD,SadoulN,etal.Arandomizedstudyofremotefollow- up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. J Cardiovasc Electrophysiol. 2014, 25(7). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578267/

9. PonikowskiP,VoorsAA,AnkerSD,etal.2016ESCGuidelinesforthediagnosisand treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016; 37(27): 2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20.

https://orbi.uliege.be/bitstream/

2268/200217/1/2016%20ESC%20Guidelines%20for%20the%20diagnosis%20and%20trea

tment%20of%20acute%20and%20chronic%20heart%20failure.pdf

10. Martin DO, Lemke B, Birnie d, et al. Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: Results of the adaptive CRT trial. Heart Rhythm Society 2012; 9(11): 1807-1814 https://www.heartrhythmjournal.com/article/S1547-5271(12)00743-6/pdf

11. Williamson BD, Gohn DC, Ramza BM, et al. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional

Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients. JACC. Clinical Electrophysiology 2017 3(11):1231-1239. https://www.sciencedirect.com/science/article/pii/S2405500X17304231? via%3Dihub